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

Yuen, K.K., Shelley, M., Sze, W.M., Wilt, T., & Mason, M.D. (2010). Bisphosphonates for advanced prostate cancer. Cochrane Database of Systematic Reviews 2010(2).

Purpose

To determine the effectiveness of bisphosphonates in relieving the bone pain of patients with bone metastases from prostate cancer

Search Strategy

  • Databases searched were MEDLINE, EMBASE, LILACS, the Database of Abstracts of Reviews of Effects (DARE), Allied and Complementary Medicine Database (AMED), and the Cochrane Central Register of Controlled Trials (CENTRAL). Investigators performed manual searches of reference lists and proceedings of the American Society of Clinical Oncology.
  • Search keywords included bone neoplasms, osseous metastasis, cancer or carcinoma and bisphosphonates or diphosphonates. Authors included an extensive list of search terms in their review.
  • Studies were included if they
    • Were randomized controlled trials that assessed the effect of bisphosphonates in prostate cancer patients with bone metastases
    • Measured pain as one of the outcome variables
  • Studies were excluded if the primary site of the cancer was not the prostate, if the treatment assessed was a radioactive bisphosphonate, or if the study was an abstract or unpublished.

Literature Evaluated

  • The search identified 23 studies. After exclusions, the set of studies to be investigated included 10 studies.
  • The sample size of the 10 studies was 1,955 patients. 
  • Range of sample size across studies was 55–378 patients.
  • Investigators evaluated study quality by using the Jadad scale.

Sample Characteristics

The final sample of 10 studies included placebo-controlled and active controlled studies of patients with prostate cancer and confirmed bone metastases.

Results

  • Four studies analyzed pain response. There was no significant heterogeneity. The overall odds ratio (OR) was in favor of bisphosphonates over placebo (OR = 1.64, 95% CI 1.02–2.61, p = 0.07).
  • Four studies assessed mean pain change. Because the four studies were extremely heterogeneous, investigators could perform no meaningful analysis.
  • In regard to analgestic consumption, investigators noted no significant heterogeneity. The overall OR showed no difference between bisphosphonates and placebo in terms of reduced analgesic consumption.
  • In regard to skeletal events, investigators noted a marginally significant difference: Incidence of skeletal effects was lower for patients using bisphosphonates than for patients using placebo (OR = 0.79, 95% CI 0.62–1.0, p = 0.05).
  • In terms of adverse events, the analysis showed a significant increase in nausea with bisphosphonates.
  • Authors also analyzed findings related to quality of life, survival, disease progression, and prostate-specific antigen.
  • No study compared different types of bisphosphonates.

Conclusions

Compared to patients receiving placebo, a higher proportion of patients receiving bisphosphonates reported a decrease in skeletal events. Use of bisphosphonates was associated with increased nausea. Findings supported the use bisphosphonates for reduction of the bone pain associated with prostate cancer. However, findings did not show that bisphosphonates made any difference in analgesic use or consumption.

Limitations

This review was limited to prostate cancer patients with bone metastases. Authors noted that findings were influenced by the way in which studies were analyzed. In general, analysis of the number of evaluable patients favored bisphosphonates, but intention-to-treat analysis revealed no difference between treatments. Invesigators also saw that results differed according to how data from active study arms were handled. In one key study, when data from study arms were analyzed individually, meta-analysis was significant; however when data from active arms were combined, investigators noted no statistical difference relating to bisphosphonate use.

Nursing Implications

Bisphosphonate appears to have a role in decreasing pain and skeletal complications in patients with metastatic prostate cancer. Nausea appears to be the most frequent side effect associated with bisphosphate use. Data are insufficient to allow researchers to determine the most appropriate bisphosphonate choice, dose, or route of administration. More research is needed to determine the most effective treatment schedules and cost-effectiveness.

Print

Yue, T., Zhuang, D., Zhou, P., Zheng, L., Fan, Z., Zhu, J., ... & He, Q. (2015). A prospective study to assess the feasibility of axillary reverse mapping and evaluate its effect on preventing lymphedema in breast cancer patients. Clinical Breast Cancer, 15, 301–306. 

Study Purpose

To determine if lymphedema prevention is affected by the use of the axillary reverse mapping (ARM) procedure

Intervention Characteristics/Basic Study Process

Two groups of patients with breast cancer receiving modified radical mastectomies were randomized to a standard axillary lymph node dissection (ALND) or ALND with ARM.

Sample Characteristics

  • N = 265
  • AVERAGE AGE = 50.14 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer diagnosis; invasive and in situ ductal carcinomas; metastatic lymph nodes from 1–10+ included; any hormone receptor or HER2 status; all tumor sizes for staging
  • OTHER KEY SAMPLE CHARACTERISTICS: Exclusion of neoadjuvant treatment patients and those with bilateral breast cancer; removal from study if experimental (ARM) group had positive ARM nodes on a pathology study

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Jinan Military Hospital in Jinan, China

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Preoperative Tc-Nanocoll injections with lymphoscintigraphy
  • Methylene blue injections
  • Intraoperative gamma probe
  • Student T test
  • Fisher exact test
  • Arm circumference measurement

Results

Between the experimental and the control group, there was a significant difference (p < 0.001) for both areas of circumference measurement in postoperative lymphedema evaluations. The experimental ARM group had less occurrence of lymphedema.

Conclusions

Based on the data presented by the investigators the incidence of lymphedema and the severity of lymphedema can be reduced by evaluating which lymph nodes really need to be removed to allow for the best lymphatic flow.

Limitations

  • Risk of bias (no blinding)
  • Other limitations/explanation: Patient weight and height or body surface area not collected (can affect lymphedema risk); no mention of prior history of breast cancer or radiation to upper body; risk factors not included such as diabetes, vascular disease, or other cancers; risk of bias; no blinding; there was no blinding for the ARM versus standard procedure; but for follow-up measurement of arm circumference for lymphedema assessment; the person measuring was blinded

Nursing Implications

Although this intervention doesn't change what staff nurses may do for patients on a day to day basis, it does allow nurses to educate patients about options as well as to open discussion with the oncology team as to the use of this newer intervention.

Print

Yuan, D.M., Li, Q., Zhang, Q., Xiao, X.W., Yao, Y.W., Zhang, Y., . . . Song, Y. (2016). Efficacy and safety of neurokinin-1 receptor antagonists for prevention of chemotherapy-induced nausea and vomiting: Systematic review and meta-analysis of randomized controlled trials. Asian Pacific Journal of Cancer Prevention, 17, 1661–1675. 

Purpose

STUDY PURPOSE: To evaluate the efficacy and safety of neurokinin-1 receptor antagonists (NK1s) for the prevention of chemotherapy-induced nausea and vomiting (CINV) among children and adolescents

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, Cochrane Library, ISI Web of Science, and a manual search of references
 
INCLUSION CRITERIA: Randomized controlled trials (RCTs) that compared NK1 (alone or combined with other antiemetics) to non-NK1s antiemetics, adequate data on the outcome or toxicity of each treatment, and prospective RCTs
 
EXCLUSION CRITERIA: Case reports, reviews, conference reports, or studies with overlapping cohorts from the same institutions

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 4,722
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Heterogeneity was evaluated with Higgins I2. Publication bias was evaluated with the Begg funnel plot and the Egger test.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 38 articles (32 for overall complete response [CR] analysis, 34 for acute CR analysis, 33 for delayed CR analysis, and 35 for toxicity analysis)
  • TOTAL PATIENTS INCLUDED IN REVIEW = 13,923 patients (12,820 for overall, 13,561 for acute, and 13,385 for delayed; number not reported for toxicity analysis)
  • SAMPLE RANGE ACROSS STUDIES: 35–1,917 patients
  • KEY SAMPLE CHARACTERISTICS: The studies occurred in multiple countries with multiple types of malignancies. NK1s were used with 5-HT3s and dexamethasone in 30 studies. Aprepitant was used in 29 studies (NK1s most common).

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Pediatrics, elder care

Results

Overall: Those with NK1 had 71% CR, and those with out NK1 (control group) had 56% CR (p < 0.001). Subgroup analysis showed that aprepitant had significantly higher CR than the control (64% versus 51%, p < 0.001), but fosaprepitant had no difference (p = 0.311). 

Acute Phase: Those with NK1 had 85% CR, and those without NK1 had 79.6% CR (p < 0.001). Subgroup analysis showed that those with oral or IV NK1 had significantly better CR (p < 0.001 for both groups) than those without NK1, but no significant difference occurred if NK1 was used intravenously on day 1 followed with oral NK1 (p = 0.685). NK1 used in combination with 5-HT3 alone or 5-HT3 plus dexamethasone had higher CR (p = 0.001 and < 0.001, respectively), but no difference occurred if NK1 was used with dexamethasone alone (p = 0.274).  

Delayed Phase: Those with NK1 had 71% CR, and those without NK1 had 58% CR (p < 0.001). Children or Adolescents: NK1 had increased CR in the overall phase (p < 0.001), acute phase (p = 0.012), and delayed phase (p < 0.001).

Other Outcomes: Compared to the control group, NK1 showed less incidence of nausea (45.2% versus 45.9%, p < 0.001), less vomiting (22.6% versus 38.9%, p < 0.001), and less use of rescue drugs (23.5% versus 34.1%, p < 0.001).

Adverse Events: NK1 did not increase the incidence of adverse events (69% versus 65%, p = 0.204), and no difference was noted among the three pediatric studies (80% versus 77%, p = 0.497).

Conclusions

The review confirms that the addition of NK1 to 5-HT3 alone or 5-HT3 plus dexamethasone is effective in achieving complete remission of chemotherapy-induced nausea and vomiting (CINV) in the acute and delayed phases with no significant increase in adverse events. The addition of NK1 is also effective for children and adolescents in the acute and delayed phases with no significant increase in adverse events.

Limitations

  • No quality evaluation
  • Low sample sizes
  • Only three studies evaluated efficacy and safety in children and adolescents

Nursing Implications

A NK1, specifically aprepitant, is effective in preventing CINV during the acute or delayed phases of treatment, but the medication should be administered consistently either orally or intravenously. Changing the IV route to oral is not effective.

Print

You, W. C., Hsieh, C. C., & Huang, J. T. (2009). Effect of extracts from indigowood root (isatis indigotica fort.) on immune responses in radiation-induced mucositis. Journal of Alternative and Complementary Medicine (New York, N.Y.), 15(7), 771-778.

Study Purpose

To evaluate the effect of indigowood root on acute mucositis induced by radiation

Intervention Characteristics/Basic Study Process

Patients gargled with 30 mL of double distilled water with 0.5g indigowood root (IR) powder for three minutes and then swallowed before meals daily. Control group did same with 30 mL of NS.

Sample Characteristics

The study was comprised of 20 patients; tx group N = 11, control group N = 9

Age Information: IR group mean age was 56.45 (SD = 10.57).

Control group mean was 57.89 (SD+ 13.11) P = 0.789. There were two females in the IR group and 0 in the control group. There were nine males in the IR group and nine in the control group.

Diagnosis Information: Nasopharyngeal cancer

Oropharyngeal, salivary gland

Setting

Single site Outpatient Tian Sheng Memorial Hospital Taiwan

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • NCI-CTC version 3
  • Body weight
  • Serum interleukin 1-beta; IL-6

Results

IR group had reduced severity of mucositis (p = 0.01). anorexia (p = 0.002), and swallowing difficulty (p = 0.002). Serum interleukin-6 was significantly lower in the IR group during the first, fifth, and seventh weeks. Resting days were fewer in the IR group but not statistically significant; body weight decreased less in IR group (p = 0.06).

Conclusions

IR may be effective to reduce the severity of maximal mucositis and improved anorexia and swallowing ability. Indirubin may play a pharmaceutical role in improvement of radiation mucositis, anorexia, and difficulty in swallowing.

Limitations

Small sample <30

Did not look at pain outcomes.

No information regarding adherence.

Nursing Implications

While this treatment may have some effect, the authors did not explore how the treatment was tolerated; patient adherence and side effects or medication interactions. Further research with this agent is warranted.

Print

Younus, J., Lock, M., Vujovic, O., Yu, E., Malec, J., D'Souza, D., & Stitt, L. (2015). A case-control, mono-center, open-label, pilot study to evaluate the feasibility of therapeutic touch in preventing radiation dermatitis in women with breast cancer receiving adjuvant radiation therapy. Complementary Therapies in Medicine, 23, 612–616. 

Study Purpose

To evaluate the feasibility of therapeutic touch (TT) in preventing radiation-induced dermatitis in patients with breast cancer who are receiving radiation treatment

Intervention Characteristics/Basic Study Process

Women with stage I and II breast cancer who had received conservative surgery and were receiving adjuvant radiation therapy were recruited for the study. TT treatment was administered three times a week following radiation therapy. Feasibility was defined as a threshold of 15 of 17 patients completing all TT treatment. The preventive effectiveness evaluation was conducted by documenting the “time to develop” and “worst grade of radiodermatitis.” Patients were followed weekly while on treatment and for one week post-treatment.

Sample Characteristics

  • N = 49   
  • AGE = 18–80 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Radiation
  • KEY DISEASE CHARACTERISTICS: Breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patient who had completed lumpectomy, sentinel lymph node biopsy, or axillary lymph node dissection

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: London Regional Cancer Program, London

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Prospective case cohort study with two arms: The control arm received the TT treatment and the experimental arm received no treatment.

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
  • European Organization for Research and Treatment of Cancer (EORTC) cosmetic rating system
  • EORTC Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
  • Profile of Mood Status (POMS)
  • Brief Fatigue Inventory (BFI)

Results

Forty-nine patients participated in the study (17 in the TT and 32 in the control). A comparison of the two groups for the worst grade of radiodermatitis showed no difference (p = 0.661). The control group median time to develop the worst toxicity was 31 days (95% confidence interval [CI] [23, 35], standard error = 1.3767); in the TT group, it took 22 days to develop the worst toxicity (95% CI [18, 24], standard error = 1.769, p < 0.001). In the control cohort, the worst grade of radiation dermatitis was grade 3 noted in one patient; in the TT cohort, the worst grade was grade 2 noted in nine patients (53%). The most common toxicity grade in 15 patients was grade 2, and three patients did not develop toxicity. There was no difference between the cohort for overall EORTC cosmetic score and no significant difference before or after the study in quality of life, mood, or fatigue scores.

Conclusions

This study was the first evaluation of TT in patients with breast cancer using objective measures and, although it was feasible for the management of radiation induced dermatitis, it was not able to detect any significant benefit on the CTCAE toxicity grade. It also did not show any improvement in outcomes for fatigue, quality of life, or mood.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results
  • Feasibility for radiation-induced dermatitis management but not for prevention

Nursing Implications

Although introducing the alternative therapy into a comprehensive cancer center was feasible and acceptable, the authors did not observe side effects and therefore were not able to detect a significant benefit of TT treatment as it related to toxicity grading or even when the toxicity developed. Because it did not improve quality of life, mood, or fatigue outcomes, it is unlikely to be effective in preventing radiation-induced dermatitis in patients with breast cancer. More studies need to be conducted in this area of alternative therapy.
Print

Younus, J., Simpson, I., Collins, A., & Wang, X. (2003). Mind control of menopause. Women’s Health Issues, 13, 74–78.

Study Purpose

The primary purpose was to observe the effect of hypnosis on hot flashes and overall QOL in symptomatic patients. A secondary objective was to observe the effect of hypnosis on fatigue.

Intervention Characteristics/Basic Study Process

Each participant had four, one-hour per week sessions of hypnosis. The same physician, with the help of a nurse, conducted every session.

Sample Characteristics

Ten healthy volunteers and four patients with breast cancer (total 14 patients) with hot flashes were enrolled.

Measurement Instruments/Methods

All participants recorded frequency, duration, and severity of hot flashes in a hot flash diary.

Results

The frequency (p < 0.0001), duration (p < 0.0001), and severity (p < 0.0001) of hot flashes were significantly reduced. The overall QOL was also improved (p < 0.05). The participants enjoyed better sleep and had less insomnia (p < 0.012). There was a significant improvement on current fatigue level (p = 0.017), but reduction in the total fatigue level was not statistically significant.

Limitations

Study limitations included pilot study nature with a very small sample size; mixed healthy participants and people with breast cancer.

Print

Young-McCaughan, S., Mays, M. Z., Arzola, S. M., Yoder, L. H., Dramiga, S. A., Leclerc, K. M., . . . Nowlin, M. U. (2003). Research and commentary: change in exercise tolerance, activity and sleep patterns, and quality of life in patients with cancer participating in a structured exercise program. Oncology Nursing Forum, 30, 441–454; discussion 441–454.

Intervention Characteristics/Basic Study Process

Patients met twice a week for 12 weeks for exercise and education. Outcomes were exercise tolerance, activity, sleep, and quality of life (QOL).

Sample Characteristics

  • The sample was comprised of 62 patients (31 men, 31 women).
  • Mean age was 55 years.
  • Patients had mixed ethnicity and varying cancer diagnoses and stages.
  • Therapy included surgery, chemotherapy, radiotherapy, immunotherapy, and endocrine and hormonal therapy.

Setting

  • Two major military medical centers
  • Inpatient and outpatient
  • Southwestern United States

Phase of Care and Clinical Applications

Patients were either undergoing the active treatment or long-term follow-up phase of care.

Study Design

This was a prospective, feasibility study with repeated measures.

Measurement Instruments/Methods

  • Wrist actigraphy to measure the duration of sleep, percentage of night spent asleep, average length of a sleep episode, and number of awakenings.
  • Cancer Rehabilitation Evaluation System–Short Form (CARES-SF) sleep item

Results

No improvement was found in sleep patterns per actigraphy; improved subjective rating was noted.

Limitations

  • This was a feasibility study; therefore, no control group was used.
  • The study had a small sample size.
  • Actigraphy data were missing.
  • Cost is incurred for actigraphs.
  • Staff must be trained in the exercise measurement.
Print

Young-McCaughan, S., & Arzola, S.M. (2007). Exercise intervention research for patients with cancer on treatment. Seminars in Oncology Nursing, 23, 264–274.

Purpose

To review research and guidelines regarding the use and potential benefits of exercise for patients with cancer undergoing treatment

Search Strategy

Databases searched were Ovid, MEDLINE, and CINAHL (1980–2007).

Sample Characteristics

  • Studies involved male and female patients with cancer undergoing treatments. The majority of studies involved women with breast cancer. Other cancers included prostate, colon, lung, stomach, endometrial, head and neck, lymphoma, multiple myeloma, and melanoma. Patients undergoing bone marrow or stem cell transplant also were represented.
  • Most studies involved patients with stage I or II disease, and some studies involved patients with metastatic disease. In patients with metastatic disease, as high as two-thirds were able to complete a 12-week program.
  • Most exercise intervention studies with patients with cancer followed the American College of Sports Medicine recommendations.  

Results

Stage of Disease:

  • Evidence suggests that, although most studies recruited from patient populations with early stage I or II disease, even patients with metastatic disease have been able to exercise successfully.
  • Stage of disease may influence exercise program completion rates.  In one study, however, almost two-thirds of the participants with stage III or IV disease were able to complete the 12-week intervention study. Patients appear to be able to safely and successfully exercise.

Types of exercise programs:

Most studies involved aerobic exercise, 11 studies included strength training, and 8 studies examined a combination of aerobic with strength training. None evaluated flexibility exclusively. 

Outcomes:

Compared to controls, the exercise groups improved cardiovascular and muscular fitness, experienced less fatigue, and slept longer. Exercise has been shown to improve almost all aspects of physiologic and psychologic functioning, including immune status. Of all the measures affected, cancer fatigue was the most improved. Although cancer fatigue has been thought to prevent patients with cancer from exercising, evidence has demonstrated that those who exercise experience less fatigue.

Frequency, intensity and adherence to exercise programs:

Participants exercised anywhere from 3–7 days a week for 2–52 weeks, for 10–45 minutes per session at 50%–85% of heart rate reserve. Adherence to the exercise prescription of frequency, intensity, time, and type ranged from 66%–78%. Typically, subjects in control groups started their own exercise programs (39%), such that diffusion of treatment effects can be an issue.

Interest:

In 2005, 63% of 187 participants agreed to join an exercise study, whereas in 2003, only 19% agreed to participate. Many hospital, clinics, and health clubs now offer programs specifically for cancer survivors. 

Concerns:

Concerns about exercise when undergoing cancer treatment have included bone metastasis, cardiac toxicities of therapies, and lymphedema. However, studies have shown that

  • Patients with bone metastasis in nonweight-bearing bones safely can exercise.
  • Exercise programs have been successfully tested to increase exercise tolerance in childhood cancer survivors who have received therapies with cardiac toxicities (e.g., anthracyclines, high-dose chemotherapy). In view of the paucity of information, one recommendation might be no exercise. However, based on the benefits of exercises in other patients with congestive heart failure symptoms, another recommendation would be to exercise as tolerated, reducing exercise intensity for symptoms, such as unusual fatigue, muscular weakness, shortness of breath, dizziness, faintness, or other unusual symptoms. 
  • Exercise has been blamed for exacerbating or triggering lymphedema, theoretically because of increased blood flow and increased metabolic waste that could trigger an increase lymphatic flow and load on an already compromised system.  However, at least three clinical trials of women with breast cancer have shown no increased risk for or exacerbation of LE from either aerobic or resistance exercise.  The recommendation is to start lymphedema patients with exercise slowly, gradually increasing the time and intensity of the exercise sessions.

Conclusions

Because of lack of research, the best mode of exercise for patients with cancer has not been determined. At the same time, no mode in any of the studies reviewed here have been determined to be harmful. Of all the nonpharmacologic interventions for cancer-related fatigue recommended by the National Comprehensive Cancer Network (NCCN), exercise has the strongest evidence.  Any exercise prescription should include the components of frequency, intensity, time, type, and progression.  Issues regarding exercise prescription in patients with cancer relate more to the treatment side effects than to the cancer itself.  Since recovery from cancer treatment is unpredictable and side effects are individual in nature, collaboration between experts in cancer care and experts in exercise physiology is essential. In general, however, frequency and duration goals should be met before intensity goals and progression should be slower and more gradual for the deconditioned patient or those who are experiencing severe side effects of treatment.

Nursing Implications

Nurses can encourage exercise as part of a patient’s therapy and guide the patient to a safe program.

Print

Yoshimoto, N., Yamashita, T., Fujita, T., Hayashi, H., Tsunoda, N., Kimura, M., . . . Iwata, H. (2010). Impact of prophylactic pyridoxine on occurrence of hand-foot syndrome in patients receiving capecitabine for advanced or metastatic breast cancer. Breast Cancer, 17, 298–302.

Study Purpose

To assess the impact of prophylactic pyridoxine on hand-foot syndrome (HFS). The impact of urea ointment on HFS also was assessed.

Intervention Characteristics/Basic Study Process

Patients who were prescribed capecitabine at two hospitals between November 1, 2006, and October 30, 2007, received prophylactic pyridoxine 60 mg per day. The results were compared to those of a control group that did not receive prophylactic pyridoxine when the patients were prescribed capecitabine. Information on the prescription of urea ointment was available for the research group; 18 were prescribed urea ointment before HFS occurred.

Sample Characteristics

  • The study reported on a sample of 38 patients in the research group and 40 patients in the control group.
  • Mean patient age was 55 years (range 31–88) for both groups.
  • All patients in the research group were women. Gender in the control group is unknown.
  • All patients had a cancer diagnosis.
  • In the research group, capecitabine was given either as monotherapy or in combination with cyclophosphamide. This was the same in the control group, except some patients also received epirubicin.

Setting

  • Multi-site
  • Outpatient
     

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a retrospective study on patients treated with capecitabine with or without prophylactic pyridoxine.

Measurement Instruments/Methods

  • HFS was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
  • Standard response criteria
  • Time to HFS was estimated using the Kaplan-Meier method and compared with the same historical data using the log-rank test.

Results

  • Twenty of the 38 patients receiving prophylactic pyridoxine (53%) developed HFS, compared with 83% of the 40 historical control patients who received no pyridoxine. 
  • Pyridoxine did not appear to reduce the severity of HFS, but a nonsignificant trend toward delayed onset of HFS existed among patients receiving pyridoxine prophylaxis versus those without.
  • A nonsignificant trend toward less-severe HFS also existed among patients who were prescribed urea ointment. 

Conclusions

Study findings did not support the effectiveness of pyridoxine in preventing HFS. Application of urea ointment may reduce the likelihood of developing HFS and prevent exacerbation to more severe HFS.  

Limitations

  •  The sample size was small (fewer than 100).
  • The research group was all women. The authors proposed this may have affected the results, as women generally tend to care more about the condition of their skin on their hands and feet than men.
  • The study had a retrospective design.
  • Different chemotherapies were used in the study and control groups.
  • Very limited sample demographic information was provided to determine key group differences that may have affected outcomes.
     

Nursing Implications

Because the data regarding prophylactic use of pyridoxine from this study contrasted with prospective data from a randomized phase 3 trial in patients with gastrointestinal disease, strongly recommending this approach is difficult. Evidence in this study is weak, and numerous limitations exist.

Print

Yorke, J., Lloyd-Williams, M., Smith, J., Blackhall, F., Harle, A., Warden, J., . . . & Molassiotis, A. (2015). Management of the respiratory distress symptom cluster in lung cancer: A randomised controlled feasibility trial. Supportive Care in Cancer, 23, 3373–3384. 

Study Purpose

To test the feasibility of a new nonpharmacologic intervention to manage the symptom cluster of respiratory distress including breathlessness, cough, and fatigue in patients with lung cancer

Intervention Characteristics/Basic Study Process

Participants received psychoeducational counseling, which consisted of controlled breathing techniques, cough-easing techniques, acupressure, and supplementary information. Participants attended two one-hour face-to-face teaching sessions, the second session given one week after the first, and then received a telephone call two weeks after the second session. The interventions were delivered by a complementary therapy team. The training for the team consisted of one three-hour face-to-face session and a follow-up refresher at the half point of the trial. Participants were asked to complete a daily diary for the first four weeks and then weekly until week 12. Participants were also asked to assess and document the usefulness of each core component or intervention; and to practice breathing and calming techniques twice a day, use education for identifying warning signs of a cough, use a modified swallow technique and relaxed throat breathing, apply pressure to identified acupressure points for one minute at least twice a day, and review information in an information packet.

Sample Characteristics

  • N = 101   
  • AGE = 67.7 years
  • MALES: 47%, FEMALES: 53%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Primary lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants with an expected prognosis of at least three months, a World Health Organization (WHO) performance status of 0–2, and who were bothered with two of the cluster symptoms (breathlessness, cough, fatigue)

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Two specialist cancer settings and two general hospitals in northern England

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Randomized, controlled trial comparing the intervention group and the control group

Measurement Instruments/Methods

Participants were randomized to either the control arm or intervention (RDSI) arm. Outcome assessments were collected at baseline, week 4, and week 12 at the end of the study. Breathlessness was measured using numerical rating scales and the dyspnea-12 scale, cough was assessed using the Manchester Cough in Lung Cancer scale (MCLC), and fatigue was assessed using Functional Assessment of Cancer Therapy–Fatigue (FACIT-F). In addition, the EQ-5D-3L was used to describe the value of quality of life (QOL), and the Hospital Anxiety and Depression Scale (HADS) was used to measure anxiety and depression.

Results

Numerical rating scales were scored lowest for ease of use and relevance, and EQ-5D-3L was scored best for ease of use and relevance. Patients rated dyspnea-12 better for ease of completion and relevance, and EQ-5D-3L and HADS demonstrated a positive pattern in improvement for the intervention group. Participants reported a high adherence to interventions with breathing exercises and acupressure, and the lower use of cough-easing techniques was likely related to the lower number of participants bothered by cough in the intervention group. The majority of participants responded favorably to breathing exercises in responses, stating that it was useful at least a little bit, and cough and acupuncture responses also were favorable but had a higher number of responses saying that it was not useful at all. No significant difference existed in breathlessness between groups.

Conclusions

This study demonstrated the feasibility and acceptability of nonpharmacologic interventions to manage symptoms of breathlessness, cough, and fatigue in patients with lung cancer. The study gave insight to the best tools/instruments to measure outcomes for larger trials that will determine improved patient outcomes with interventions. This study also revealed patients' willingness to learn new strategies and complete study requirements for data collection. The results trended better outcomes in the treatment group, but the trial was not large enough to draw conclusions.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Subject withdrawals ≥ 10% 
  • The sample size calculation indicated that a larger sample size is needed to determine whether or not the intervention resulted in improved patient outcomes and is cost-effective compared to the control group.

Nursing Implications

Nurses play an important role in identifying and managing patients with the respiratory distress symptom cluster. The study suggests the potential role for nurses to educate patients or to refer patients to complementary practioners who will instruct them on breathing techniques, cough-easing techniques, and acupressure.

Print
Subscribe to