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Doss, J.J.K. (2014). Effectiveness of foot massage on level of pain among patients with cancer. Asian Journal of Nursing Education and Research, 4, 228–231.

Study Purpose

To evaluate the effectiveness of foot massage on pain in patients with cancer 

Intervention Characteristics/Basic Study Process

This research was a nonrandomized, two-group, quasi-experimental time series design conducted among 60 patients with cancer. The experimental group received a 30-minute foot massage over a three-day period. Pain was assessed using the Numeric Rating Scale for pain, which used a 0–10 range. Pain was assessed prior to the intervention and after the intervention for three days.

Sample Characteristics

  • N = 60  
  • AGE RANGE = 39–58 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Diagnosis of cancer within last one to three years with chronic-type pain in the second stage of cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: All were Hindu

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Devaki Cancer Hospital and Research Institute in Madurai, India

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

Nonrandomized, two-group, quasi-experimental, time series trail

Measurement Instruments/Methods

  • Numeric Rating Scale (NRS) for pain

Results

On day 1, all patients in both groups reported severe pain. On day 2, most of the patients reported moderate pain with no measurable differences between the two groups. On day 3, the experimental group reported mild to no pain, and there was no change in the control group from day 2. The intervention group experienced a significant reduction in pain (p < 0.001).

Conclusions

This study shows the need to understand the purpose of foot massage techniques on pain levels in patients with cancer. The researcher assumed that with a decrease in pain, there would be an increase in patients' quality of life including stability in physiologic, psychological, sexual, vocational, and lifestyle aspects. These areas were not measured, and additional research is needed.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import: Did not identify types of cancer
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias(sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results: Did not identify any medications given for pain
  • Key sample group differences that could influence results: Cancer diagnoses not identified
  • Measurement/methods not well described: Unclear when intervention was done in response to pain assessment  
  • Findings not generalizable
  • Other limitations/explanation: The use of the NRS for pain is very subjective. It is unclear when or where the assessment was done in relation to the intervention. Although all the patients were female, the types of cancer studied were not reported. Different types of cancer can cause many different types of pain in different locations. The second stage of cancer was not defined. The types of pain medications used were not defined. The positions of those providing the intervention and their training were not identified. It is unclear if the foot massages were done consistently between patients using similar techniques.

Nursing Implications

Foot massage is an easy and cost-effective nursing intervention that could be used to help ease patient pain. This research article identified the need to continue research in this area. The patient parameters need to be more specific in future research designs.

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dos Santos, L.V., Souza, F.H., Brunetto, A.T., Sasse, A.D., & da Silveira Nogueira Lima, J.P. (2012). Neurokinin-1 receptor antagonists for chemotherapy-induced nausea and vomiting: A systematic review. Journal of the National Cancer Institute, 104(17), 1280–1292.

Purpose

To evaluate the overall effectiveness and safety of neurokinin 1 (NK1) receptor antagonists (RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) when compared to standard antiemetic regimens including a 5-HT3 RA plus dexamethasone

Search Strategy

Databases searched were MEDLINE, Embase, Cochrane Central Register of Controlled Trials (Central), and Latin American and Carribean Health Sciences Literature (LILACS).

Search keywords were neurokinin, aprepitant, casopitant, ezlopitant, netupitant, vestipitant, chemotherapy-induced nausea and vomiting, nausea in cancer patients, vomiting in cancer patients, and randomized trials.

Studies were included in the review if they

  • Were randomized controlled trials (RCTs) that addressed the addition of an NK1 RAs to standard antiemetic therapy (dexamethasone plus 5-HTRA) for the prevention of CINV.
  • Provided an adequate description of outcomes that could be pooled in the meta-analysis.
  • Used adequate antiemetic therapy in the control arm.

No specific exclusion criteria were identified.

Literature Evaluated

A total of 4,034 references were retrieved.

Two reviewers assessed the quality of each study. Items from Delphi list and Jadad score were utilized for data extraction; however, the authors did not describe if any specific scoring system was used for quality assessment.

Sample Characteristics

  • The final number of studies included was 17.
  • The sample range across all studies was 36–1,933.
  • The total number of patients included in the review was 8,740. Data from 8,173 patients in 13 studies were used for analysis about complete response (CR), which is defined as no vomiting, no retching, and no use of rescue medication. Data from 8,376 patients from 15 studies were used for acute and delayed phase analysis.
  • All patients were diagnosed with cancer and receiving either highly or moderately emetogenic chemotherapy.

Phase of Care and Clinical Applications

All patients were in active antitumor treatment.

Results

  • The use of an NK1 RA increased the CR rate in the overall phase from 54% to 72% (overall response [OR] = 0.51, 95% confidence interval (CI) = 0.46–0.57, p < 0.001), in the acute phase (OR = 0.56, 95% CI = 0.48–0.65, p < 0.001), and in the delayed phase (OR = 0.48, 95% CI = 0.42–0.56, p < 0.001).
  • The addition of an NK1 RA to standard antiemetic therapy improved CR rates in the overall phase for patients who received highly emetegenic chemotherapy (OR = 0.46, 95% CI = 0.40–0.53, p < 0.001) or moderately emetogenic chemotherapy (OR = 0.59, 95% CI = 0.51–0.67, p < 0.001).
  • The addition of an NK1 RA increased CR rates in the overall phase independently depending on if ondansetron was used in the control arm beyond day 1 or not (ondansetron: OR = 0.64, 95% CI = 0.54–0.76, p < 0.001; no ondansetron: OR = 0.47, 95% CI = 0.41–0.53, p < 0.001). CR in the acute phase and delayed phase demonstrated a strong correlation (r = 0.91, p < 0.001).
  • Three trials (n = 1,480) suggested a statistically significant increase (from 2% to 6%) in the risk of severe infection among patients receiving NK1 RAs (OR = 3.10. 95% CI = 1.69–5.67, p < 0.001).

Conclusions

The addition of an NK1 RA increased CINV control in the acute, delayed, and overall phases.

The use of an NK1 RA may be associated with a statistically significant increase in the risk of severe infection. A more comprehensive evaluation of the safety profile of NK1 RAs and additional appraisal of specific data from RCTs is needed.

Limitations

  • Subgroup analysis requires careful scrutinization. In this review, most patients in the moderately emetogenic chemotherapy group received an AC regimen, which is now considered highly emetogenic chemotherapy.
  • Favorable ondansetron use for the delayed phase was suggested after comparing its effect with placebo control. However, current guidelines suggest the use of dexamethasone rather than ondansetron as a combination regimen for delayed CINV control. Comparison should have been between an NK1 RA plus dexamethasone versus NK1 plus ondansetron.
  • Toxicity analysis was based on reports  of 3 studies (out of 17 studies included) which reported on the most prevalent adverse events. NK1 RA use did not increase the risk of febrile neutropenia or any other hematologic toxicity. OR findings are not clearly interpretable.

Nursing Implications

  • This systematic review summarized the results from RCTs which investigated the effect of an NK1 RA for CINV control. Overall, the use of an NK1 RA improved the CR in acute, delayed, and overall phases.
  • Further studies are warranted to determine whether adding an NK1 RA to standard antiemetics could improve CINV control in non-AC, moderately emetogenic chemotherapy as most NK1 RA RCTs were based on cases receiving highly emetogenic chemotherapy (including an AC regimen).
  • Although further study is warranted, occurrence of infection with NK1 use requires special attention.
Print

dos Santos Martins, S.P., Ferreira, C.L., & del Giglio, A. (2017). Placebo-controlled, double-blind, randomized study of a dry guarana extract in patients with head and neck tumors undergoing chemoradiotherapy: Effects on fatigue and quality of life. Journal of Dietary Supplements, 14, 32–41.

Study Purpose

To determine if the use of guarana extract affects fatigue or quality of life in patients with head and neck cancer undergoing chemoradiotherapy

Intervention Characteristics/Basic Study Process

Patients were randomized to receive either guarana or placebo, with both given twice daily before meals for six weeks while they were undergoing chemoradiotherapy. The patients receiving guarana took 50 mg twice daily. The patients were assessed three times throughout treatment at day 1, day 21, and day 42, and once three weeks after the completion of treatment on day 63. The three assessments during treatment corresponded with cisplatin administration. Each assessment included fatigue and quality of life questionnaires, evaluation for guarana toxicity according to the World Health Organization scale, as well as weight and renal function.

Sample Characteristics

  • N = 52   
  • AGE = Not specified
  • MALES (%): Not specified, FEMALES (%): Not specified
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stage I–IV head and neck cancer, mainly squamous cell carcinoma. Patients underwent 30 sessions of radiotherapy and three cycles of cisplatin.

Setting

  • SITE: Not stated/unknown   
  • SETTING TYPE: Not specified    
  • LOCATION: Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Phase II, placebo-controlled, double-blind, randomized study

Measurement Instruments/Methods

  • General questionnaire
  • Guarana Toxicity Assessment 
  • Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
  • Functional Assessment of Cancer Therapy-Head and Neck (FACIT-HN), version 4.0
  • European Organization of Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-30) questionnaire
  • EORTC QLQ-H&N-35 questionnaire

Results

No statistically significant reduction in fatigue or improvement in quality of life was identified in either group using any questionnaire. Some initial or transient improvements were noted but were not statistically significant or did not last the length of treatment. The authors do not recommend the use of guarana in this patient population.

Conclusions

This intervention was not successful for this patient population. Although the authors reported some positive benefits, based upon the description of the results, it is unclear if this is related to the guarana or other factors that could influence quality of life in the patient population.

Limitations

  • Small sample (< 100)
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%

Nursing Implications

In terms of nursing practice, this study highlights the significance of malnutrition, weight loss, and mucositis in this patient population, and addressing these complications of chemotherapy and radiation in this patient population seems like a promising area for nursing attention and research.

Print

Dorr, W., & Herrmann, T. (2007). Efficacy of Wobe-Mugos E for reduction of oral mucositis after radiotherapy: Results of a prospective, randomized, placebo-controlled, triple-blind phase III multicenter study. Strahlentherapie und Onkologie, 183(3), 121–127.

Intervention Characteristics/Basic Study Process

Proteolytic enzymes comprised of papain (100 mg), trypsin (40 mg), and chymotrypsin (40 mg) were administered orally 3 x 4 tablets per day.

Sample Characteristics

The study reported on 69 patients with tumors of the oropharynx or oral cavity undergoing a radiation dose higher than 40 Gy.

Setting

The study was conducted at a multicenter site from June 1996 to May 2000.

Study Design

This was a prospective, randomized, triple-blind, placebo-controlled, parallel group study.

Measurement Instruments/Methods

  • Maximum grade of mucositis was recorded.
  • The Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) toxicity criteria were used.

Results

No statistically significant difference was found in analysis. Treatment with Wobe-Mugos E resulted in an earlier onset of mucositis and increased average scores for treatment duration.

Limitations

The sample was not sufficient according to power analysis.

Print

Döring, M., Hartmann, U., Erbacher, A., Lang, P., Handgretinger, R., & Müller, I. (2012). Caspofungin as antifungal prophylaxis in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation: a retrospective analysis. BMC Infectious Diseases, 12, 151.

Study Purpose

The primary objective was to evaluate the safety of caspofungin (CAS) in pediatric patients following allogeneic hematopoietic stem cell transplantation (HSCT) when compared with intravenous (IV) liposomal amphotericin B (L-AmB).  The secondary objectives evaluated the incidence of aspergillosis, candidiasis, and other fungal infections in pediatric patients following allogeneic HSCT.

Intervention Characteristics/Basic Study Process

This was a retrospective analysis of pediatric patients receiving either CAS or L-AmB after allogeneic HSCT between January 2006 and June 2010.  All patients received L-AmB (1 mg/kg/day) during conditioning from day –8 through day 0.  Patients who underwent transplantation between January 2006 and August 2008 were continued on L-AmB until oral antimycotic therapy was started prior to discharge (group 1).  All patients undergoing transplantation between September 2008 and June 2010 were switched to CAS starting on day 1 until oral antimycotic therapy was started prior to discharge (group 2).  The observation period was defined as the time from the start of IV antimycotic prophylaxis until three weeks after switching to oral antimycotic prophylaxis three to four days before inpatient discharge.  Patients were observed for tolerability, safety, and efficacy of caspofungin, and infection rates were compared between the two groups.

Sample Characteristics

  • One hundred twenty patients were included.
  • Patients were younger than 18 years.  Twenty patients were younger than 6 years in the L-AmB arm and 17 were in the CAS arm; 24 patients were aged 6 to 11 years in L-AmB arm and 20 were in the CAS arm; and 16 patients were aged 12 to 18 years in the L-AmB arm and 23 were in the CAS arm.
  • In the L-AmB arm, 55% of patients were male and 45% were female.  In the CAS arm, 63.3% of patients were male and 36.7% were female.
  • Key disease characteristics were patients with hematologic malignancies.  Nonmalignant hematologic disorders and inborn errors of metabolism undergoing allogeneic HSCT were evaluated. The L-AmB arm included patients with acute lymphoblastic leukemia (ALL) (30%), acute myeloid leukemia (AML) (11.7%), juvenile myelomonocytic leukemia (JMML) (5%), chronic myelogenous leukemia (CML) (5%), myelodysplastic syndromes (MDS) (10%), non-Hodgkin Lymphoma (NHL) (1.7%), solid tumors (15%), aplastic anemia (1.7%), neurometabolic diseases (8.3%), immunodeficiency (6.7%), Chediak-Higashi syndrome (3.3%), and Morbus Kostmann (1.7%).  The CAS arm included patients with ALL (28.3%), AML (1.7%), JMML (3.3%), MDS (8.3%), NHL (5%), solid tumors (16.7%), aplastic anemia (16.7%), neurometabolic diseases (8.3%), and immunodeficiency (11.7%).
  • In the L-AmB arm, 53.4% of patients had some degree of graft-versus-host disease; in the CAS arm, 61.9% of patients had any degree of graft-versus-host disease.

Setting

  • Single site 
  • Inpatient 
  • University Children’s Hospital Tubingen, Germany

Phase of Care and Clinical Applications

  • Patients were undergoing the active antitumor treatment phase of care.
  • The study has clinical applicability for pediatrics.

Study Design

This was a single-center, retrospective study.

Measurement Instruments/Methods

Biochemical laboratory results were measured.

Results

Leukopenia was observed for a median duration of 12 days in both groups.  Median duration of therapy was 23 days (range 9–72) in group 1 (L-AmB) and 24 days (range 14–49) in group 2 (CAS).  There was no incidence of proven aspergillosis or another invasive fungal infection in either group.  No proven fungal breakthrough infections were observed in either group three weeks after the conclusion of IV fungal therapy.  No patient died of an invasive fungal infection. Clinical side effects related to treatment were observed in 8.3% of patients in group 1 and 3.3% in group 2, with four patients in the L-AmB arm being switched to CAS due to side effects.  There was a statistically significant but transient increase in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) in both groups, and hypokalemia occurred significantly (p = 0.006) in the L-AmB arm (group 1).

Conclusions

This study retrospectively showed that the efficacy of the two antifungal agents used for prophylaxis was good with no proven invasive fungal infection noted in either group.  This could be an option to limit the side effects and potential nephrotoxicity noted in L-AmB administration.  Larger, prospective studies are needed for true recommendations.

Limitations

  • Risk of bias (no control group, no blinding, no random assignment, no appropriate attentional control condition)
  • Findings not generalizable*

* Findings may not be generalizable to adult patients, but they could be generally applied to pediatric patients undergoing allogeneic HSCT, which is a small group.

Nursing Implications

Nursing is imperative in the monitoring and administration of medications in this setting.  The need for monitoring, especially for infusion reactions, hypokalemia, and nephrotoxicity, is higher in those receiving L-AmB.  The use of CAS may reduce this need, but nurses must still be vigilant to identify fever or other symptoms in these patients.

Print

Döring, M., Blume, O., Haufe, S., Hartmann, U., Kimmig, A., Schwarze, C. P., . . . Muller, I. (2014). Comparison of itraconazole, voriconazole, and posaconazole as oral antifungal prophylaxis in pediatric patients following allogeneic hematopoietic stem cell transplantation. European Journal of Clinical Microbiology & Infectious Diseases, 33, 629–638. 

Study Purpose

To explore the efficacy of itraconazole, voriconazole, and posaconazole for breakthrough fungal infections with a secondary objective of analyzing the safety and feasibility of these three different regimens in a pediatric hematopoietic stem cell transplantation (HSCT) population

Intervention Characteristics/Basic Study Process

This study consisted of the observation of 150 pediatric patients split into three groups between the ages of 0.6–17.7 years with hematologic malignancies undergoing allogeneic HSCT. All patients received one of the azoles as primary oral antifungal prophylaxis following HSCT. Fifty consecutive patients from 2006 to 2007 were in the itraconazole group, 50 consecutive patients from 2006 and 2010 in the voriconazole group, and 50 consecutive patients from 2010 to 2011 were in the posaconazole group when the center switched to posaconazole for prophylaxis. The observation period lasted from the start of oral prophylactic treatment till two weeks after the withdrawal of therapy.

Sample Characteristics

  • N = 150  
  • AGE: All patients were aged less than 18 years
  • MALES: 54%, FEMALES: 46%
  • KEY DISEASE CHARACTERISTICS: Majority were hematological malignancies, but also included some solid tumors, neurometabolic disease, and immunodeficiency syndromes; all underwent HSCT 
  • OTHER KEY SAMPLE CHARACTERISTICS: Conditioning regimens and transplant type (MUD, MMUD, MMFD, and MFD)

Setting

  • SITE: Single site  
  • SETTING TYPE: Inpatient    
  • LOCATION: University Children’s Hospital Tübingen

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Retrospective, single-center survey; one sample t-test used the Wilcoxon matched-pairs signed-rank test

Measurement Instruments/Methods

  • Proven probable and possible invasive fungal infections classified according to the National Institute of Allergy and Infectious Disease Mycoses Study Group
  • Galactomannan antigen testing

Results

Possible invasive fungal infections occurred in 4% of the itraconazole group, 6% of the voriconazole group, and 0% of the posaconazole group. There were no significant differences comparing all three. Adverse events occurred in 12% of the itraconazole group, 14% of the voriconazole group and 8% of the posaconazole group (no significant difference). All three groups showed a significant increase in ALT and AST as well as a significant difference between baseline and maximum levels of ALT and AST without clinical symptoms. Bilirubin also was increased during all three drug regimens but remained within the upper limits of normal. The kidney parameters (BUN/Cr) also showed an increase in all three groups but were not above reference values. Other adverse effects included hyponatremia. Cyclosporine (CsA) levels were evaluated in select patients in all three groups requiring dosage adjustments with a 12% dose reduction of CsA in the itraconazole and voriconazole group and as much as a 25% dose reduction in the posaconazole group.

Conclusions

Current guidelines for the use of oral antifungal prophylaxis in pediatric patients after HSCT are based on insufficient data. Despite the positive results, showing efficacy of all three drugs, it was comparable with no proven or probable fungal invasive infections. The analysis of a larger number of patients is required.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Other limitations/explanation: The majority of patient’s received IV liposomal amphotericin or IV caspofungin prior to the switch to oral monoprophylaxis, and this may have been a positive contributing factor to prevent invasive fungal infections. The interpretation that there was no significant difference in side effects – due to a few occurrences in the posaconazole arm the power was low at 16.2% – urges caution when interpreting the difference.

Nursing Implications

Because of the small number of current trials, larger trials are needed to compare each of the azoles as monoprophylaxis. Additional studies are needed to better understand the side effect profiles of the azoles and their interactions with antibiotics or immunosuppressants.

Print

Donnelly, C. M., Blaney, J. M., Lowe-Strong, A., Rankin, J. P., Campbell, A., McCrum-Gardner, E., . . . Gracey, J. H. (2011). A randomised controlled trial testing the feasibility and efficacy of a physical activity behavioural change intervention in managing fatigue with gynaecological cancer survivors. Gynecologic Oncology, 122, 618–624.

Study Purpose

To determine the feasibility and efficacy of a physical activity (PA) behavioral change intervention on managing cancer-related fatigue among gynecological cancer survivors during and after anticancer treatments.  

Intervention Characteristics/Basic Study Process

After telephone screening and written informed consent, blinded baseline assessments were conducted prior to randomization via a computer-generated random numbers table. Participant randomization was stratified according to treatment status (i.e., currently in treatment versus posttreatment). The intervention included an initial personal consultation with a physiotherapist who educated patients about the benefits of PA and discussed behavioral change strategies. Weekly telephone calls were used to reinforce education, identify barriers to PA, and set activity goals. A final consultation was held to establish longer-term goals and review the program. The control group also received weekly telephone calls for the duration of the intervention in order to match the attention provided to the experimental group.

Sample Characteristics

  • In total, 33 participants (100% female) were included.    
  • Age was 18 years or older.
  • Participants had ovarian (n = 12) and endometrial (n = 11) tumors, and the remaining participants (n = 10) had uterine, cervical, and mixed gynecological tumors. Participants were diagnosed with gynecological cancer stage I to III, had completed surgery, and were currently undergoing treatment or were postanticancer treatment within three years of diagnosis (average of nine months postdiagnosis).
  • Interested participants were screened for eligibility via the telephone.
  • Participants reported mild to moderate fatigue (1–10 numeric rating scale) and were currently sedentary (vigorous PA less than 20 minutes/week or moderate PA less than 60 minutes/week, for the past six months).

Setting

  • Single site  
  • Northern Ireland regional Cancer Centre

Phase of Care and Clinical Applications

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for late effects and survivorship.

Study Design

The study was a two-arm, single-blind, randomized, control trial comparing a 12-week, home-based, moderate intensity, PA behavioral change intervention to a contact control (CC) group.

Measurement Instruments/Methods

  • Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
  • Functional Assessment in Chronic Illness Therapy-Fatigue (FACIT-F) subscale
  • Functional Assessment of Cancer Therapy-General (FACT-G) scale
  • Beck Depression Inventory II (BDI-II)
  • Positive and Negative Affect Schedule (PANAS)
  • Body mass index (BMI)
  • Waist circumference
  • 12-minute Walk Test
  • Pittsburg Sleep Quality Index (PSQI)
  • Self-reported Seven-Day Physical Activity Recall

Results

Four of 16 women in the PA group did not receive the intervention. The primary outcome, MFSI-SF, showed that the PA group had a significant decrease in fatigue postintervention (week 12) and at six-month follow-up compared to the CC group, with moderate to large effect sizes (d = 0.2; p = 0.001). The largest effect size on the MFSI-SF was on follow-up, suggesting that the benefits increased after completion of the 12-week intervention. No significant differences were found on any other secondary outcomes. The adjusted difference between means at follow-up for quality of life was clinically significant in favor of the PA group. No measurement tool for quality of life was specified by the authors. A mean of 10 telephone calls was made to both the PA and CC groups, with positive perception of the intervention based on exit questionnaires and focus group findings.

Conclusions

A PA behavioral change intervention is feasible with regard to program adherence and evaluation. The intervention may be helpful in improving fatigue.

Limitations

  • The study had a small sample size.
  • The study lacked statistical power.
  • The results were not generalizable.
  • No standardized objective measure of PA was used.
  • The high rate of ineligibility among women screened limited the sample size.
  • There was a 25% drop-out rate for participants assigned to intervention group.
     

Nursing Implications

Suggestions for further study include

  • Larger randomized, controlled trials to confirm the effects of the PA behavioral change intervention on fatigue
  • Follow-up beyond six months
  • The high rate of ineligibility suggests a need to investigate interventions for those ineligible due to comorbidities and advanced disease; one might question if an activity intervention in these subgroups would be advisable and if one would see a difference in participation/adherence to the program and similar benefits to the participants in this intervention group.
  • Stratification according to tumor type may reveal differences between and among groups. 
  • Encouraging  findings, both quantitative and qualitative, for eligible participants suggests efficacy and implies a need for testing in a larger multicenter study. The question remains as to whether time may be all that is necessary to modify cancer-related fatigue in this population.
Print

Donnelly, J.P., Bellm, L.A., Epstien, J.B., Sonis, S.T., & Symonds, R.P. (2003). Antimicrobial therapy to prevent or treat oral mucositis. Lancet Infectious Diseases, 3, 405–412.

Search Strategy

Database searched was Medline (1964–June 2002).

Keywords searched were anti-infective agents and mucositis or stomatitis

Articles were included in the review if they were written in English language and described human clinical trials.

Studies were excluded if they involved meta-analyses.

Study quality was scored on 0–5 scale (with 5 being the highest) depending on previously established criteria. Five studies scored 4, and eight scored 0. The mean score was 2.1, indicating overall lack of quality in published material.

Literature Evaluated

Thirty-one eligible studies were identified. Twenty-eight of the studies used some kind of control, usually a placebo mouthwash or sterile water. Seventeen studies assessed chlorehexidine, and five studies investigated preparations containing polymyxin, tobramycin, and amphotericin; others included povidone-iodine; fluconazole; clindamycin; bacitracin, clotrimazole, and gentamicin; tetrachlorodecaoxide, ciprofloxacin, or ampicillin with clortrimazole; sucralfate versus sucralfate; ofloxacin, miconazole, tetracain, and guaiazulene; triacetin versus topical anesthetics or system icanalgesics; tetracycline, nystatin; hydrocortisone; and diphenhydramine versus placebo. The chlorexidine studies also included the following agents: benzydamine, nystatin, povidone-iodine, salt and soda, magic mouthwash, and clotrimazole.

The scale used was reported in 22 studies. Scales were World Health Organization (n = 4), Oral Assessment Guide (n = 7), 0–5 scale (n = 1), and 0–4 scale (n = 10).

Sample Characteristics

The number of patients across studies ranged from 12–275.

Results

  • Of the 30 studies reporting a measurable outcome, 14 reported a benefit, 15 reported no benefit, and 1 reported an unfavorable outcome.
  • Of the 17 studies involving chlorhexidine, one had an unfavorable outcome (i.e., increased oral mucositis and discomfort), 11 showed no benefit, and 7 groups showed some benefit.
  • Four of the studies using other agents reported a benefit, four reported no benefit, and one reported only microbiologic data.

Conclusions

No clear pattern emerged regarding the benefit of antimicrobial use to manage oral mucositis.

Nursing Implications

Results draw attention to the multifaceted pathophysiology of oral mucositis, which presents a challenge for effective measures for prevention and treatment of mucositis.

Print

Dong, X., Huang, J., Cao, R., & Liu, L. (2010). Palonosetron for prevention of acute and delayed nausea and vomiting in non-small-cell lung carcinoma patients. Medical Oncology, 28, 1425–1429.

Study Purpose

To verify the activity and safety of palonosetron in patients with non-small cell lung cancer treated with chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomized to either a single dose of 0.25 mg IV bolus palonosetron or 8 mg IV ondansetron on day one. Only dexamethasone was permitted as rescue medication. Doctors recorded daily episodes of vomiting and nausea and use of rescue medication. Patients were followed for seven days.

Sample Characteristics

  • The study consisted of 89 participants.
  • The mean age was 53 years (range 29–76).
  • The sample was 32% female and 57% male.
  • Patients were diagnosed with non-small cell lung cancer, stages II–IV, and were receiving highly emetogenic chemotherapy (HEC).
  • Of the palonosetron group and the ondansetron group, 68% and 64%, respectively, had previously received chemotherapy. More than 50% of these patients had experienced chemotherapy-induced nausea and vomiting (CINV).

Setting

The study was conducted at a single site in China.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a randomized, controlled study.

Measurement Instruments/Methods

The following measurement were used.

  • Daily episodes of vomiting (number, duration, time)
  • Nausea intensity based on a 0–3 Likert-type scale
  • Use of rescue medication
  • Complete response (CR): no emesis, no rescue medication
  • Complete control (CC): no emesis, no rescue medication, no more than mild nausea
  • Common Terminology Criteria for Adverse Events, version 3.0 (CTAE 3.0)

Results

  • The proportion of patients with CR and CC in the delayed phase was significantly higher in the palonosetron group than in the ondansetron group (p < 0.02).
  • The proportion of patients with no nausea was greater in the palonosetron group (23%) than in the ondansetron group (12%) in the delayed phase (p = 0.013).
  • The proportion of patients with no emesis was greater in the palonosetron group than in the ondansetron group in the delayed phase (p < 0.000).
  • In the palonosetron group, the proportion of patients with no emetic episodes throughout the study was 61.4%, compared to 31.1% in the ondansetron group (p = 0.004).
  • The adverse events profiles of palonosetron and ondansetron group were not statistically different. Constipation and headache were the most frequent adverse events.

Conclusions

Palonosetron could be an effective and safe drug for the prevention of CINV associated with HEC. Palonosetron may be particularly helpful in prevention of CINV in the delayed period.

Limitations

  • A small sample of fewer than 100 participants was used.
  • Appropriate emetic control was not employed because the chemotherapy regimen was HEC and aprepitant and dexamethasone are recommended antiemetics for the control of CINV with HEC.

Nursing Implications

In countries where aprepitant is not widely available, palonosetron could be an option for 5-HT3 receptor antagonists for CINV with HEC among patients with non-small cell lung cancer.

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Donald, G.K., Tobin, I., & Stringer, J. (2011). Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy. Acupuncture in Medicine, 29, 230–233.

Study Purpose

The aim of the study is to explore the potential effectiveness of acupuncture in the treatment of chemotherapy-induced peripheral neuropathy.

Intervention Characteristics/Basic Study Process

Once a patient's clinical condition had been assessed as suitable for acupuncture, he or she was initially offered a course of six weekly treatments. Patient suitability to receive acupuncture was assessed prior to each session. All acupuncturists were qualified nurses trained in the Western medical approach (WMA) and needles remained in situ for 30–45 minutes. Acupuncturists selected points to be used based on patient presentation at each session. Treatments took place either in an outpatient clinic, chemotherapy day case ward, or a drop-in clinic based in a physiotherapy gym. An evaluation form was completed by the therapist prior to the first session and on completion of the final (sixth) session. A different member of the team completed this final evaluation to minimize bias.

Sample Characteristics

  • A total of 17 participants were enrolled.
  • The mean age was 51.83 years (SD = 12.97), and women (53%) slightly outnumbered men (47%).
  • Key disease characteristics of the participants include a variety of solid tumors and hematologic malignancies.
  • Another key characteristic is peripheral neuropathy refractory to standard care.

Setting

The study was conducted in a single-site outpatient setting at an acute cancer care hospital in northwest England.

Phase of Care and Clinical Applications

Phase of care

  • Active treatment
  • Transitions

Applications

  • Late effects or survivorship

Study Design

The study was a retrospective service evaluation.

Measurement Instruments/Methods

  • No validated instruments were used. Instead, patients were asked to categorize their symptoms  as improved, unchanged, aggravated, increased, or other.
  • Additional benefits were recorded, including relaxation, reduced stress, better sleep, improved mood, less medication, and other.   

Results

Patients reported improved neuropathy symptoms following acupuncture.

Limitations

  • The study was a published QA project plagued with risks to validity, including the possibility of social response bias.
  • Other limitations include a small sample size, a retrospective design, and a lack of validated instruments.

Nursing Implications

No implications for nursing can be made from this study.

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