Skip to main content
We are aware of current issues with the ONS login. Users who already have an account with ONS should clear their device history/cache before attempting to log in. Thank you.
cancel

Wong, K.H., Kuciejewska, A., Sharabiani, M.T., Ng-Cheng-Hin, B., Hoy, S., Hurley, T., . . . Newbold, K.L. (2016). A randomised controlled trial of Caphosol mouthwash in management of radiation-induced mucositis in head and neck cancer. Radiotherapy and Oncology, 122, 207–211.

Study Purpose

To evaluate the efficacy of Caphosol mouthwash in the management of patients with head and neck cancer receiving (chemo)radiotherapy who have radiation-induced oral mucositis (OM)

Intervention Characteristics/Basic Study Process

Prior to receiving (chemo)radiotherapy, patients were randomized 1:1 to receive a standard oral care regimen (control) with or without Caphosol mouthwash. Those patients randomized to Caphosol used it from week 1–6 of radiation and then one week postradiation, at least four times per day, but could be increased up to 10 times per day per the patient or physician discretion. Other interventions for symptom control were allowed during the study. The patients randomized to the control arm received standard OM treatment per the institutions guidelines, which consisted of normal saline rinses at least four times per day, fluoride toothpaste with brushing, and aspirin mouthwash three times per day. Training on the use of Caphosol was provided by EUSA Pharma.

Sample Characteristics

  • N = 215   
  • MEAN AGE = 58.8 years (SD = 10.6)
  • MALES: 74.9%, FEMALES: 25.1%
  • CURRENT TREATMENT: Radiation, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Carcinoma of the head and neck receiving (chemo)radiotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria of 18 years of age or older and a Karnofsky Performance Status greater than 70%. Induction chemotherapy and concomitant platinum-based chemotherapy or cetuximab were allowed at the discretion of the physician. Exclusion criteria were previous radiation therapy to head and neck, baseline OM, and carcinoma of the thyroid and larynx. Patients were stratified by type of radiation therapy (unilateral versus bilateral) and whether or not they were receiving chemoradiation versus radiotherapy alone.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Royal Marsden Hospital, UK

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Phase III, single institution, non-blinded, randomized, controlled trial

Measurement Instruments/Methods

Patients were assessed at baseline and prospectively every week for six weeks during radiation therapy and until four weeks postradiation therapy. Physicians trained on the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, performed the scoring of radiation-induced adverse events. Quality of life was assessed at baseline, week 4 of radiation therapy, week 4 of postradiation therapy, and week 8 of postradiation therapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Model (EORTC QLQ-C30), version 3.0, and the Quality of Life Questionnaire Head and Neck Module (QLQ-HN35).

Results

Primary endpoint:
  • Incidence of grade 3 or higher OM during and up to eight weeks after radiation therapy. This study showed no benefit in the incidence of OM (64.1% Caphosol versus 65.4 control, p = 0.839).
Secondary endpoints:
  • Duration of grade 3 or higher OM; no difference
  • Incidence and duration of pharyngeal mucositis; lower incidence and shorter duration but NCS
  • Incidence and duration of severe dysphagia; lower incidence and shorter duration but NCS
  • Incidence and duration of severe radiation-induced pain; lower incidence and shorter duration but NCS
  • Patient-reported quality of life; no difference

Conclusions

In this large study, prophylactic Caphosol mouthwashes with standard OM treatment did not show a benefit versus standard OM treatment alone in reducing the incidence of OM or shortening the duration of OM in patients receiving (chemo)radiotherapy for head and neck cancer.

Limitations

  • Risk of bias (no blinding)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Patients were not stratified by primary site of disease; therefore, patients who were at high risk were not evenly distributed between treatment groups.
  • The number of completed quality of life questionnaires were significantly lower than predicted, possibly because of the length and the toxicities patients were experiencing later in the study.
  • Patients did not adhere to the prescribed use of Caphosol during the entire study period because of taste, nausea, or perceived lack of benefit.
  • Single site—not generalizable

Nursing Implications

No evidence suggests that this intervention would benefit the type of patients studied. The cost of Caphosol would not be warranted, and its use could actually negatively affect patients because of the poor taste and potential for nausea.

Print

Wong, R., & Wiffen, P.J. (2009). Bisphosphonates for the relief of pain secondary to bone metastases. Cochrane Database of Systematic Reviews 2009(4).

Purpose

To determine the effectiveness of bisphosphonates as a treatment for pain in patients with bone metastases

Search Strategy

  • Databases searched were MEDLINE, CANCERLIT, the Cochrane Library, and the Oxford Pain Relief Database.
  • Keywords searched were bisphosphonates, diphosphonates, multiple myeloma, and bone neoplasm.
  • Studies were included if they
    • Reported on patients with bone metastasis.
    • Were randomized controlled trials (RCTs).
    • Were reports of bisphosphonate use.
    • Were full research reports (no abstracts).
    • Included pain or analgesic use as an outcome measure.

Literature Evaluated

The initial search identified 85 studies, of which 30 met inclusion criteria. Study quality was evaluated using the Jadad scale. Five studies included pain as a primary endpoint.

Sample Characteristics

The final sample of 30 studies included 3,582 patients. Types of diagnoses included breast and prostate cancer, multiple myeloma, and other types of primary tumors.

Results

  • Drugs studied included etidronate, clodronate, and pamidronate. In 22 of the 30 studies, additional hormone therapy or chemotherapy was used.
  • Proportion of patients with pain relief: Across eight studies, pooled data showed significant pain relief with treatment (OR = 2.37, 95% CI 1.61–3.5).
  • Average pain score effects: Seven studies showed a general trend in favor of treatment, though data were insufficient to allow pooled analysis. Differences between treatment and control groups ranged from –0.037 through –0.53. Most studies used a visual analog scale measurement.
  • Analgesic consumption:
    • Three studies showed no differences between groups.
    • Three studies showed less increase in analgesic consumption with treatment.
  • Adverse effects:
    • Twenty-four studies reported nonsignificant increases in nausea and vomiting.
    • Three studies reported an adverse effect that necessitated discontinuation of therapy.
    • Other effects reported were abdominal pain, allergic response, and hypocalcemia.

Conclusions

Results of this review suggest that one of six patients treated with a bisphosphonate will receive modest pain relief. Results suggest that 1 of 11 patients treated with a bisphosphonate will experience side effects severe enough to justify discontinuing bisphosphonate treatment. Overall, data were insufficient to allow investigators to recommend the use of a bisphosphonate to achieve an immediate effect. Findings show that the maximum response to bisphosphonate-related pain management can be observed by four weeks.

Limitations

  • Study results do not provide information about effects beyond 12 weeks.
  • Most studies used insufficient, unvalidated pain outcome measures.

Nursing Implications

Bisphosphonates appear to help reduce the pain of bone metastases in some patients. Long-term efficacy is unclear. The effects of bisphosphonates on pain appear to be at the maximum at four weeks of use. Effects appear to be stable up to 12 weeks. Efficacy after 12 weeks has not been studied. Studies reviewed in this investigation reported little data; the result is the inability to analyze results quantitatively across studies. Future research should incorporate valid pain measures and report results.

Print

Wong, S.L., Leong, S.M., Chan, C.M., Kan, S.P., & Cheng, H.W. (2015). The effect of using an electric fan on dyspnea in Chinese patients with terminal cancer: A randomized controlled trial. American Journal of Hospice and Palliative Care. Advance online publication.

Study Purpose

To measure the effect of using electrical fans as a nonpharmacologic nursing treatment to relieve dyspnea among Chinese patients with progressive cancer

Intervention Characteristics/Basic Study Process

The study used a single-blinded trial whereby the participants, dyspneic patients with advanced cancer, were allocated randomly to either the experimental group or the control group. For ethical reasons, both groups were given the same nursing or medical interventions when dyspnea transpired, which included oxygen therapy, rescue medications, and semi-Fowler's positioning. The participants in the experimental group received the fan therapy when dyspneic, which involved the use of an electrical fan directed to the face with a low flow rate for five minutes. Baseline demographics, medical diagnosis, hemoglobin levels, and drug treatments were recorded before the intervention was made. Furthermore, clinical parameters including a numeric rating scale (NRS), respiratory rate (RR), and SpO2 were taken before and after each use of the fan therapy.

Sample Characteristics

  • N = 30   
  • AGE = Adults
  • MALES: 47%, FEMALES: 53%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: The main cancer diagnosis of the participants was carcinoma of the lung.
  • OTHER KEY SAMPLE CHARACTERISTICS: Other diagnoses included colorectal, stomach, breast, and prostate cancers as well as lymphoma. Of the patients, 96.7% required chronic oxygen therapy during the study. All patients were Chinese. Inclusion criteria included patients capable of expressing that they had dyspnea and baseline dyspnea level on numeric rating scale (NRS) of 3 or higher. Excluded patients had a fever or acute shortness of breath, and were mentally incompetent or unwilling to participate.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Hospice and Palliative Care Center of Kiang Wu Hospital, China

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Elder care, palliative care 

Study Design

  • Randomized, control trial

Measurement Instruments/Methods

  • Verbal NRS from 0–10 signifying “no shortness of breath” to “very severe shortness of breath.” Patients were shown a colored picture with words and figures along with numbers on the rating scale, and respondents either pointed to picture or stated a number aloud. 
  • Finger pulse oximeter indicating the SpO2 and RR

Results

In the experimental group, participants' self-reported breathlessness score was 6.13 and 4.6 before and after intervention, respectively, demonstrating a 1.53 improvement after the intervention (p < 0.01). However, other measurement parameters comprising the RR and SpO2 exhibited no significant improvement (p > 0.05). After recording the second assessment postintervention for the experimental group, the control group was given the fan therapy. No substantial change in self-reporting, RR, and SpO2 was noted.

Conclusions

The results of this randomized, control trial showed a significant improvement in self-reporting of breathlessness among the participants in the intervention group using fans. Since dyspnea is a subjective symptom, self-report in improvement of dyspnea demonstrates a positive outcome despite no improvement in RR or SpO2.

Limitations

  • Small sample (< 100)
  • Risk of bias (no appropriate attentional control condition)
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10% 
  • Subjects all were Chinese, so results may not be generalizable to the general population.
  • The authors concluded that the control group did not demonstrate improvement in dyspnea when offered the fan later because it was not offered immediately; this would need to be further tested prior to making that assumption.

Nursing Implications

These findings shed light on new interventions that nurses could use to alleviate dyspnea in their patients with cancer. In addition, because the intervention is cheap and practical (no needed training), it could be one of the most ideal interventions for a nurse to use. Further studies incorporating larger and culturally diverse sample sizes are recommended for validation. People of Chinese heritage may ascribe to the belief that, in Chinese medicine, a “cold pathogen” may attack and harm the body; as a result, they may be concerned that prolonged exposure to fan therapy may give them a cold or a headache; therefore, they may be resistant to its use for reasons not related to efficacy in mitigating dyspnea.

Print

Wong, S.F., Lindgren, A., Mummaneni, M., Byun, T., Vasko, C., Arenos, R., ... Osann, K. (2010). A prospective crossover pilot study to evaluate the use of a topical wound gel in patients with cutaneous toxicity caused by epidermal growth factor receptor inhibitors. The Journal of Supportive Oncology, 8, 202–208.

Study Purpose

To evaluate the effectiveness of Regenecare® Wound Gel in alleviating the pain and pruritus of EGFR-induced (EGFRI) rash

Intervention Characteristics/Basic Study Process

Enrolled patients received Regenecare® Wound Gel, a viscous hydrogel wound dressing with 2% w/w lidocaine. Facial assessments were conducted weekly for up to six weeks, and patient self-report questionnaires were collected weekly. Patients who developed grade 2 or higher rash applied the gel to the right side of the face three to four times per day for one week. In weeks 2–5, patients applied the gel three to four times per day to both sides of the face. Compliance data were collected at each visit, and patients whose adherence fell below 75% received specialized counseling. If patients were not adherent for two consecutive weeks, they were removed from the study.

Sample Characteristics

  • N = 13
  • MEDIAN AGE = 51.2 years
  • MALES: 54%, FEMALES: 46%
  • KEY DISEASE CHARACTERISTICS: Majority of patients had colorectal cancer and were receiving cetuximab.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Orange County, California

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care 

Study Design

Prospective, crossover

Measurement Instruments/Methods

  • CTCAE version 3.0 for Rash/Desquamation
  • Pain scale (none, mild, moderate, severe)

Results

When the right and left sides of the face were compared, the gel was associated with a significant reduction in pruritus (p = 0.01) but no significant decrease in pain level. The gel also had minimal effect on erythema and swelling as assessed by healthcare providers.

Conclusions

The hydrogel decreased pruritus associated with EGFR-inhibitor associated rash but did not have any influence on pain associated with the rash.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias(sample characteristics)
  • Findings not generalizable

 

Nursing Implications

Nurses should assess patients with EGFR-associated rash for pruritus, including intensity and the level to which it affects patient comfort. Regenecare® Wound Gel may be an effective topical intervention to relieve pruritus and should be considered for a topical treatment. There is no benefit to using the gel for pain relief, and nurses should consider other interventions if patients experience pain associated with the rash.

Print

Wong, R.K., Bensadoun, R.J., Boers-Doets, C.B., Bryce, J., Chan, A., Epstein, J.B., . . . Lacouture, M.E. (2013). Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group. Supportive Care in Cancer, 21, 2933–2948. 

Purpose & Patient Population

PURPOSE: To develop evidence-based guidelines to prevent and treat skin toxicity (acute and late) from radiation therapy. Use of these guidelines was intended for practitioners who encounter patients with skin changes associated with radiation therapy.
 
TYPES OF PATIENTS ADDRESSED: Patients who have received or will receive radiation therapy

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline
 
PROCESS OF DEVELOPMENT: The Skin Toxicity Study Group is one of 17 study groups of the Multinational Association for Supportive Care in Cancer (MASCC). The first original search was from 1980–2004 and was used by the Cancer Care Ontario guideline group. This search was updated in 2010 for a book chapter on radiation dermatitis, including the original search strategy from 1980–2004 in addition to a search without language restriction for 2004–August 2010. For the MASCC guideline, a second update from 2010–April 2011 was conducted for the meeting. A final update was completed in July 2012 prior to publication of the manuscript.

DATABASES USED: MEDLINE for initial and subsequent updates; PreMEDLINE, Cochrane Library, and CANCERLIT for the original search 1980–2004; Embase for 2010–2012; and conference proceedings of the American Society of Clinical Oncology for 2004–2012. National Guidelines Clearinghouse was used for existing practice guidelines.

KEYWORDS: Radiation dermatitis for acute reactions; telangiectasia and cutaneous fibrosis for late reactions

INCLUSION CRITERIA: Randomized controlled trials, guideline papers, meta-analyses, and systematic reviews. Studies that included any control group met the definition of a controlled study. Inclusion required that grade of skin reaction was evaluated as an outcome with primary interest greater or equal to moist desquamation. Pain, itching, and quality of life also were included if available. For late reaction dermatitis, trials using prospective designs were used.

EXCLUSION CRITERIA: Unpublished articles

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference

Acute radiation dermatitis recommendations were based on guidelines consisting of four general systematic reviews, two for specific topics, two evidence-based guidelines, and one consensus guideline. There were 56 randomized controlled trials–45 prevention, 9 treatment, and 1 combined prevention and treatment. Late radiation effect recommendations were based on one RCT; one prospective, observational study; and two prospective, single-arm studies.

Guidelines & Recommendations

Strong recommendation:
  • Gentle washing with water (mild soap or shampoo optional)
  • Antiperspirants during breast radiation therapy
  • Prophylactic topical steroids (mometasone) for risk reduction of discomfort and itching
 
Weak recommendation:
  • Prophylactic silver sulfadiazine cream in patients with breast cancer to reduce radiation dermatitis score
 
Strong recommendation against:
  • Prophylactic aloe vera or trolamine
 
No recommendation possible:
  • Prophylactic topical sulcrate/derivatives, hyaluronic acid, ascorbic acid, silver leaf dressing, LED, Theta-Cream, dexpanthenol, and calendula
  • Oral proteolytic enzymes, sucralfate, zinc, and pentoxifylline in standard clinical practice
 
Established radiation-induced telangiectasia and fibrosis:
  • Weak recommendation for pulse dye laser for visual appearance
  • Weak recommendation against pentoxifylline for reduction of fibrosis in standard clinical practice
 
Patient education materials:
  • Validation prior to use
  • Sixth grade reading level and tables preferred
  • Specific products to purchase with examples
  • Behaviors to avoid
  • Contact information for physician and when to call for symptom management

Nursing Implications

Nurses need to keep updated on current studies and guidelines related to care of patients receiving radiation therapy as well as potential acute and long-term effects to the skin. Nurses are in a unique position to educate staff and patients on evidenced-based skin care. Potential skin care practices for patients undergoing radiation need to be evaluated through well-designed research studies.

Print

Won, Y., Hwa, Choi, Y., Jung, Ahn, S., Lee, J., Park, J., Yun, Kim, S., . . . Kim, Y.H. (2014). Improving the quality of cancer pain management in an academic medical center emergency department. Clinical Journal of Oncology Nursing, 18, 626–629. 

Study Purpose

To evaluate the impact of a cancer-related pain control project implemented in a specialized cancer emergency department

Intervention Characteristics/Basic Study Process

A project to improve the management of cancer-related pain was implemented in a cancer emergency department that was established two years prior. The project used standard operating procedures for patient assessments every eight hours and reported any pain within one hour of analgesic administration. The pain management guidelines used included the use of oral analgesics following the World Health Organization analgesic ladder, the use of time-release analgesics for the prevention of pain recurrence, the prophylactic prescription of immediate-release analgesica for breakthrough pain, and the increase of the regular analgesic dose when breakthrough pain occurred more than three times per day. The target pain score on a numeric rating scale was established at three points or less. Medical records were reviewed to obtain study data, and adherence to the guideline and procedures was ranked low, medium, or high based on percent adherence. Findings prior to and after the project's implementation were compared.

Sample Characteristics

  • N = 455
  • MEAN AGE = 54.9 years
  • MALES: 50%, FEMALES: 50%
  • KEY DISEASE CHARACTERISTICS: The majority of patients had solid tumors of various types.
  • OTHER KEY SAMPLE CHARACTERISTICS: The patients included were those in the emergency department for at least 24 hours.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Korea

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

Retrospective, descriptive study

Measurement Instruments/Methods

  • Pain severity Numeric Rating Scale (NRS)
  • Time to reaching target pain NRS score of three or less
  • Guideline adherence high (> 75 %), medium (50%–75%), and low (< 50%)

Results

The percentage of patients who received pain assessments according to the procedure increased after the intervention (p < 0.001). There was a significant improvement in the appropriate use of short-acting analgesics (p < 0.001), prescriptions for breakthrough pain analgesics (p = 0.013), and the use of time-release analgesics (p < 0.001). The time to reach the target NRS was 27 hours before the intervention and 15 hours after (p = 0.025). There was a significant correlation between guideline adherence and time to reach the target NRS score (p = 0.039).

Conclusions

The use of standard guidelines and standard operating procedures for the treatment of cancer-related pain was associated with improved frequency of assessment and time to reach a target pain score.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Other limitations/explanation: The intervention was done in a cancer-specific emergency department. Such a specialized emergency department is not usual. There was no description of how the project and its related changes in practice were actually implemented or what staff education efforts were done to implement the guidelines and procedures.

Nursing Implications

The findings of this study suggest that organizational initiatives to improve pain control with guidelines and standard operating procedures can improve the management of cancer-related pain.

Print

Wolf, S.L., Qin, R., Menon, S.P., Rowland, K.M., Jr, Thomas, S., Delaune, R., . . . Loprinzi, C.L. (2010). Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. Journal of Clinical Oncology, 28, 5182–5187.

Study Purpose

To determine the effectiveness of a urea/lactic acid–based topical keratolytic agent (ULABTKA) for the prevention of capecitabine-induced hand-foot syndrome (HFS).

Intervention Characteristics/Basic Study Process

Eligible patients received their first dose of capecitabine at 2,000 or 2,500 mg/m2 per day for 14 days, every 21 days. Patients then were randomized to the ULABTKA arm or placebo cream. Creams were applied to the hands and feet BID for 21 days over four consecutive cycles. Patients kept a daily diary. Toxicity data were collected at baseline and the end of each 21 day cycle. The primary end point was incidence of moderate or severe HFS in the first cycle, based on patient report. Secondary end points included the incidence of moderate or severe HFS by physician grading, times to grade, and physician determination.

Sample Characteristics

  • The study reported on a sample of 127 patients. Of 137 total patients enrolled, only 67 on study drug and 60 on placebo reported characteristics and outcomes.
  • Twenty patients were aged younger than 50 years, 36 were aged from 50 to 60 years, and 71 were aged older than 60 years.
  • The sample was 84% female, 16% male, and 96% Caucasian.
  • Sixty-five percent of the sample had breast cancer, 23% had lung cancer, and 11% had colon cancer.
  • All patients were to receive their first cycle of capecitabine; 85% were on metastatic treatment and 14% were on adjuvant treatment.

Setting

  • Multi-site
  • Outpatient
  • North Central Cancer Treatment Group (NCCTG)

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, double-blind, phase 3 clinical trial.

Measurement Instruments/Methods

  • All patients were provided information regarding initial signs and symptoms of HFS.
  • Patients completed a self-reported HFS diary daily.
  • Physicians determined HFS grades for symptoms with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, at baseline and the end of each 21-day cycle.
  • Patients completed a symptom experience diary at baseline and each week.
  • Patients were queried about the occurrence of rash and diarrhea at each visit.

Results

  • No significant differences were observed in toxicities between the two groups across all visits.
  • With regard to primary end point, the difference between the two study arms was not statistically significant. In fact, the incidence of moderate-to-severe HFS was higher in the treatment arm.

Conclusions

The use of urea/lactic acid for the prevention of HFS in patients receiving capecitabine therapy cannot be supported on the basis of this trial.

Limitations

The primary end point only concerned the first 21-day cycle, rather than looking over the planned four cycles. This raises the question over whether more power could have existed to detect smaller differences. More patients received the lower dose of capecitabine.

Nursing Implications

Nurses should educate patients to limit or not use urea/lactic acid cream if starting on capecitabine.

Print

Wolf, H.H., Leithäuser, M., Maschmeyer, G., Salwender, H., Klein, U., Chaberny, I., Weissinger, F., . . . Infectious Diseases Working Party of the German Society of Hematology and Oncology. (2008). Central venous catheter-related infections in hematology and oncology: Guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Annals of Hematology, 87, 863–876.

Purpose & Patient Population

To identify risk factors for developing catheter-related infections (CRIs) and interventions to prevent CRIs in patients with central venous catheters (CVCs)

 

Type of Resource/Evidence-Based Process

The guidelines were developed by reviewing studies to identify populations at risk and interventions effective in preventing CRIs. Key words searched included catheter-related infections, guidelines, neutropenia, antimicrobial treatment, infection prophylaxis, and biofilm.

Results Provided in the Reference

Strict procedures for hygiene during insertion of CVCs are effective in avoiding infections. CVC insertion through the subclavian vein rather than the internal jugular is better for preventing infections, but other risks, including severe hemorrhage, need to be assessed.  

For dressing changes and insertion site prep, chlorhexidine solution is preferred over aqueous polyvidone-iodine solutions, and alcoholic chlorhexidine solution, alcoholic polyvidone solutions, or 70% propranolol are alternatives noted to be safe. One randomized, controlled study showed that using alcoholic chlorhexidine in sequence with aqueous polyvidone-iodine was superior to using them as single agents.

Routine catheter replacement, systemic prophylactic antibiotic therapy prior to catheter insertion, and applying antibiotic ointment to the catheter site all show no benefit in preventing infections. Sterile gauze dressing changes every two days and transparent film dressings changed weekly are recommended in the absence of inflammation or loss of dressing integrity, but more frequent dressing changes do not reduce CRIs.

Infusion tubing is recommended to be changed every 72 hours with the exception of systems used for lipid emulsions recommended to be changed every 24 hours. Transfusion tubing should include standard filters for red blood cells or platelets and German regulations are specific about filter changes every six hours, noting that replacing filters at earlier intervals does not lower infection rate. Only one randomized trial of patients with cancer with nontunneled minocycline/rifampin-coated CVCs reported a decrease in bloodstream infections that were catheter-related. Recent randomized studies do not show a correlation between CRIs and the number of catheter lumen, as reported by earlier nonrandomized studies recommending single-lumen catheters.

Guidelines & Recommendations

Recommendations include

  • Adhering to hygiene principles when inserting CVCs and employing standardized aseptic placement, using subclavian vein versus internal jugular vein for vascular access, and using catheters impregnated with antiseptics like chlorhexidine/silver sulfadiazine or antibiotics including minocycline/rifampin have been effective in reduction of catheter colonization. 
  • Educating nurses and physicians.
  • Using ultrasound guidance during insertion. 

Routine replacement of catheters is not effective in reducing CRIs. Antibiotic ointment at insertion site or applied to nostrils is not recommended. Systemic antibiotics are not recommended prior to CVC insertion as prophylaxis.

Limitations

  • No conflict of interest concerns were addressed.

Nursing Implications

Age (pediatrics), grade of neutropenia, catheter type, disease diagnosis, nurse-to-patient ratio, administration of parental nutrition, and number of days the patient has the CVC may all contribute to the risk of developing CRIs. It was suggested in two studies that in the hematologic/oncologic population, subclinical thrombosis of the catheterized vein as seen on ultrasound could be a significant risk factor for developing CRIs. Although some of the studies show benefit of antibiotic flushes to reduce CRIs, there are no prospective randomized, double-blind studies involving adults or pediatric patients with hematologic or solid tumors to determine if this practice will result in development of resistant bacteria. Although recommendations were shown in text and table using the A–E, I–III grading and evidence, no definitions or key were presented in this article.

Print

Wohlrab, J., Bangemann, N., Kleine-Tebbe, A., Thill, M., Kummel, S., Grischke, E.M., . . . Luftner, D. (2014). Barrier protective use of skin care to prevent chemotherapy-induced cutaneous symptoms and to maintain quality of life in patients with breast cancer. Breast Cancer, 6, 115–122. 

Study Purpose

To test the effectiveness of a topical application of a niacinamide-containing, barrier-protective preparation in women with breast cancer undergoing treatment with anthracyclines or taxanes

Intervention Characteristics/Basic Study Process

This prospective, randomized, reference-controlled crossover study began on the first day of chemotherapy. One study group (group 1) received the test preparation (TP) for six weeks then standard care (SC) for six weeks. Group 2 started with six weeks of SC then crossed over to six weeks of TP. TP consisted of a shea butter lipophilic cream containing 4% niacinamide and thermal spring water from La Roche-Posay as the hydrophilic phase (Lipikar Baume AP®; La Roche-Posay Laboratoire Pharmaceutique, La Roche-Posay, France). TP was applied twice daily on the whole body. SC consisted of patients' usual body care. This was used as the control arm. Data were collected for 12 weeks.

Sample Characteristics

  • N = 73
  • AGE RANGE = 25–77 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients who were diagnosed with breast cancer and who were scheduled to receive taxane or anthracycline chemotherapy in an adjuvant or neoadjuvant setting with or without trastuzumab
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients could not have dysfunctional skin barrier signs, atopic or psoriatic skin history, or have been prescribed or using over-the-counter compounds with vasoactives, anti-inflammatory agents, diuretics, or medications affecting lipid metabolism.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Not specified    
  • LOCATION: Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care  

Study Design

Multicenter, prospective, randomized, reference-controlled crossover study

Measurement Instruments/Methods

  • The Dermatology Life Quality Index (DLQI): Six DLQI subscales were included in the analysis.
  • Symptoms of pruritus, dryness, and skin irritability were quantified using a Visual Analog Scale (VAS).

 

Results

Total DLQI scores after six weeks were not significantly different. There was a significant difference on the “symptoms and feelings” DLQI subscale after week 4 (p = .06). Secondary parameters of pruritus (p = .034), dryness (p = .0002), and irritability (p = .0312) revealed significant differences for TP after six weeks.

Conclusions

Anthracyclines and taxanes cause dry, itchy skin. Total DLQI scores indicated that the treatment was not superior to the control in preventing skin toxicities associated with anthracycline and taxane therapy in women with breast cancer. Results from the VAS indicated that the experimental treatment may improve pruritus, dryness, and skin irritability. No safety concerns were raised by participants in this trial.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: This study, although randomized, was not blinded. Measurement tools were discussed but not provided. Dropout rates were caused by patients stopping chemotherapy. This study was not generalizable due to the homogeneity of the sample.

Nursing Implications

Skin and cutaneous side effects from chemotherapy affect the quality of life of patients dealing with cancer diagnoses. The ability to suggest proactive interventions gives healthcare providers the opportunity to promote patient independence and show an understanding of patients' physical and social needs. Without untoward effects, it would seem appropriate to suggest niacinamide-containing creams as a possible preventive treatment for skin care during chemotherapy with anthracyclines or taxanes to decrease dryness, pruritus, and skin irritability in this population. Nurses should share the limitations of this study when discussing the evidence it produced. Research on this compound in patients with other diagnoses using these chemotherapy agents could strengthen the level of evidence.

Print

Wiskemann, J., Dreger, P., Schwerdtfeger, R., Bondong, A., Huber, G., Kleindienst, N., . . . Bohus, M. (2011). Effects of a partly self-administered exercise program prior to, during, and after allogeneic stem cell transplantation. Blood, 117, 2604–2613.

Study Purpose

The primary aim was to identify the benefits of exercise performed during the entire hematopoietic stem cell transplantation (HSCT) time period. The secondary aim was to explore endurance performance via six-minute walk test (6MWT), isometric muscle strength, functional performance status, physical activity levels via pedometer step count, health-related quality of life, and psychological well-being and distress.

Intervention Characteristics/Basic Study Process

A self-administered exercise intervention was compared to a social contact pedometer-wearing control group. Exercise began one to four weeks prior to hospital admission. Exercise included three endurance (outpatient:  walking; inpatient:  bicycling and treadmill) and two resistance (color-coded bands with different levels of resistance focused on extremities, entire body, and bed exercises) training sessions per week (up to five sessions during hospitalization). Exercise continued six to eight weeks after discharge. The control group reported that moderate physical activity was helpful without instruction, wore step counters, and received thirty minutes of physiotherapy and access to bicycles and treadmills during hospitalization. Both groups received the same number of visits by study personnel.

Sample Characteristics

  • One hundred five patients were enrolled, and 80 (40 in each group) were included in the final analysis.
  • Mean age was 48.8 years. 
  • Thirty-four females and 71 males were included. 
  • Patients had acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), lymphoma, and aplastic anemia.

Setting

  • Multisite
  • University Clinic, Heidelberg, Germany and the German Diagnostic Clinic, Wiesbaden, Germany

Study Design

This was a prospective, multicenter, randomized, controlled trial.

Measurement Instruments/Methods

  • Borg Scale – perceived exertion scale
  • Multidimensional Fatigue Inventory (MFI)
  • Profile of Mood States (POMS)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Daily log
  • 6MWT protocol by the American Thoracic Society estimated aerobic capacity
  • Hand-held dynamometer measured maximal isometric voluntary strength
  • National Comprehensive Cancer Network (NCCN) Distress Thermometer
  • Hospital Anxiety and Depression Scale (HADS)

All assessments were measured at four time points:  baseline, admission, discharge, and six to eight weeks after discharge.

Results

Significant group differences at the end of the intervention were:  general fatigue (p = 0.009); physical fatigue (p = 0.01); and POMS fatigue scale (p = 0.004). The exercise group was superior to the control group in all subscales. Physical capacity increased in the exercise group (p = 0.02) and was inversely correlated with general fatigue (p ≤ 0.01). The Intervention significantly improved the strength of the lower extremities (p = 0.03) (maybe due to walking and biking). The exercise group was significantly more anxious than the control group (p = 0.007). All benefits were observed most predominantly during hospitalization.

Conclusions

This partly supervised exercise intervention was beneficial for patients undergoing allogeneic (allo)-HSCT.

Limitations

  • The study had a small sample size, with less than 100 patients. 
  • The 6MWT was not a standard procedure for assessing endurance capacity.
  • Interrater reliability was unknown for the hand-held dynamometer.
  • Exercise logs were missing (most before and during hospitalization).
  • There was no documentation about social support for the control group.

Nursing Implications

The allo-HSCT patient population should be encouraged to exercise. An exercise intervention is feasible and can alter cancer-related fatigue in the allo-HSCT patient population. Use of preadmission exercise in concert with findings of differences in fatigue between individuals who have higher baseline activity levels suggests that further research in improving capacity and activity levels prior to treatment in various patients is worth investigating.

Print
Subscribe to