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Chen, K.W., Berger, C.C., Manheimer, E., Forde, D., Magidson, J., Dachman, L., & Lejuez, C.W. (2012). Meditative therapies for reducing anxiety: A systematic review and meta‐analysis of randomized controlled trials. Depression and Anxiety, 29, 545–562.

Purpose

STUDY PURPOSE: To investigate all types of meditative therapies for overall efficacy and effect size for reducing anxiety in various types of patients
TYPE OF STUDY: Meta-analysis and systematic review
 

Search Strategy

DATABASES USED: PubMed, EMBASE, PsycInfo, Cochrane collaboration Qigong database
KEYWORDS: Keywords incorporated various types of practices including yoga, reiki, guided imagery, and mindfulness.
INCLUSION CRITERIA: RCT, anxiety was an outcome with a psychometric measure, sample size of more than 20, anxiety level data provided for baseline and postintervention
EXCLUSION CRITERIA: Qualitative report, literature review, combined measure of anxiety and stress, no psychometric measure of anxiety alone

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,030 references were retrieved.

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Use the CLEAR = NPT quality checklist. Most studies did not provide the information needed for quality assessment. Sixteen studies had good quality, and 17 had moderate or acceptable quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 40; 36 in meta analysis
  • SAMPLE RANGE ACROSS STUDIES: 18–207
  • KEY SAMPLE CHARACTERISTICS: Only 3 studies included were done with patients with cancer. Several studies were done with healthy subjects and college students.

Phase of Care and Clinical Applications

PHASE OF CARE: Not provided

Results

In meta-analysis, overall results in comparison to wait list controls to interventions had standard mean difference (SMD) of –0.52 (95% confidence interval [CI] [–0.79, –0.41]). Results in comparison to attention control condition had SMD of –0.59 (95% CI -[–0.79, –0.39]). Results in comparison to an alternative intervention had SMD of –0.27 (95% CI [–0.46, –0.09]). Studies conducted in China and Japan had larger effect sizes, and lower quality studies had larger effect sizes.

Conclusions

Interventions incorporating meditative practices have overall positive effects on mood.

Limitations

Very few studies included patients with cancer, and the review incorporated findings from normal health controls as well as individuals with various acute and chronic diseases. All types of practices including imagery and those involving movement were considered together. Although there are certainly some similarities in the mental components of many of these practices, it is unclear that they would be routinely viewed as the same. Many studies also included counseling, education, and psychoeducational types of components, which can be expected to confound results.

Nursing Implications

Findings suggest that in the general population and patients with various types of chronic disease, interventions that involve incorporation of mindfulness and meditative types of practice may be beneficial in reducing anxiety. The application specifically forcancer care is difficult to determine because there were so few studies involving patients with cancer. Nurses can expect that some patients may benefit from meditative practices, and these approaches may be more acceptable to some ethnic groups.

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Chen, H.M., Tsai, C.M., Wu, Y.C., Lin, K.C., & Lin, C.C. (2014). Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer. British Journal of Cancer, 112, 438–445. 

Study Purpose

To determine the effectiveness of a 12-week, home-based walking exercise program in managing anxiety, depression, and the severity of cancer-related symptoms while investigating the psychological effects of home-based walking exercises on patients with lung cancer

Intervention Characteristics/Basic Study Process

116 patients were randomly assigned to the walking-exercise group (58) or the usual-care group (58). The exercise program consisted of a 12-week, home-based, moderate-intensity walking exercise of 40 minutes per session with three sessions per week and weekly exercise counseling. Patients were given a booklet and instructions on the mode intensity and frequency of exercise, pulse rate measurement, Borg’s rating of perceived exertion scale (RPE), prevention of sports injuries, and the time point of terminating the exercise. The participant was to achieve a target heart rate of 50%–80% based on the Korvonen method and a score of 13–15 on the RPE scale. Measurements were recorded at three time points: baseline, three months, and six months.

Sample Characteristics

  • N = 116  
  • AGE RANGE = 37–88 years
  • MALES: 54, FEMALES: 62
  • KEY DISEASE CHARACTERISTICS: Primary lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Excluded if patient participated in regular exercise or received cognitive behavior therapy in the past six months

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care, palliative care 

Study Design

Parallel, randomized, controlled, single-center trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • Taiwanese MD Anderson Symptom Inventory (MDASI)
  • Statistical analysis: Intention-to-treat (ITT) approach

Results

There were no statistically significant differences in the baseline demographic data, disease characteristics, or baseline physical activity between the two groups. 44.8% of the exercise group completed the intervention. The exercise adherence rate was 59.7%. No exercise-related adverse effects were observed during the study period. The mean anxiety score of the walking exercise group declined by 1.04 points between baseline and the six-month completion. This was not statistically significant. The mean anxiety score of the usual care group at the third month increased significantly (mean difference = 1.72, P = 0.012) and remained stable until the sixth month. The anxiety scores of the walking exercise group declined by 0.63 points at the third month and by 1.03 points at the sixth month. A significant interaction term of the model at the third month and sixth month verified that the walking exercise reduced anxiety over time. The mean depression scores of the walking exercise group gradually declined, but there was no statistical significance. The mean depression scores for the usual care group significantly increased by the sixth month (mean difference = 1.35, P = 0.071). Participants engaging in walking exhibited additional reductions in depression over time. The mean symptom scores of the walking exercise group declined from baseline to the third month and remained stable. The mean symptom scores of the usual care group remained unchanged from baseline. A marginally significant difference between both groups was seen at the third month (1.50 versus 2.08, P = 0.053).

Conclusions

The authors concluded that the walking exercise program effectively reduced anxiety and depression over time. The benefits of exercise demonstrated in other cancer populations applied to patients with lung cancer as well. No substantial reduction was observed regarding the effect of the exercise program on symptom relief. However, the symptom scores of the exercise group were marginally lower over time. Adherence and dropout rates suggested that regular follow-up calls and encouragement to continue exercise would be beneficial.

Limitations

  • Risk of bias (no blinding)
  • Unintended interventions or applicable interventions not described that would influence results 
  • Selective outcomes reporting 
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Generalized symptom improvements in a large subset of symptoms (i.e., pain, fatigue, nausea, sleep disturbance, sadness, shortness of breath, difficulty remembering, poor appetite, drowsiness, dry mouth, distress, vomiting, numbness) instead of measuring the outcomes of a targeted symptom

Nursing Implications

Exercise is a valuable intervention for anxiety and depression in patients with cancer. Nurses should consider education and training for patients to establish regular exercise programs as a supportive care intervention.

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Chen, M.H., May, B.H., Zhou, I.W., Zhang, A.L., & Xue, C.C. (2016). Integrative medicine for relief of nausea and vomiting in the treatment of colorectal cancer using oxaliplatin-based chemotherapy: A systematic review and meta-analysis. Phytotherapy Research, 30, 741–753. 

Purpose

STUDY PURPOSE: To assess whether integrative management of colorectal cancer, in which traditional medicines are added to oxaliplatin regimens, reduced the incidence of chemotherapy-induced nausea and vomiting (CINV) and to determine if specific particular traditional medicines provided enough evidence to pursue further research for CINV

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed, EMBASE, Cochrane CENTRAL, CINAHL, Science Direct, PsycINFO, China Academic Journals, and Chinese Science and Technology Journals
 
INCLUSION CRITERIA: Adults with colorectal cancer at any stage, randomized controlled trials that used an oxaliplatin regimen combined with a traditional medicine in the test group (could be single substance or multi-ingredient formulation). Concurrent use of antiemetics was permitted.
 
EXCLUSION CRITERIA: None listed

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 2,163
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The researchers removed (a) preclinical studies, (b) studies that included traditional medicine plus oxaliplatin versus a oxaliplatin design, and (c) studies that did not report outcomes for nausea and vomiting or did not have data deemed “suitable for pooling.”

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 27 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,843
  • SAMPLE RANGE ACROSS STUDIES: 16–74 patients
  • KEY SAMPLE CHARACTERISTICS: Adult patients from China and Australia with a colorectal diagnosis

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Across all 27 studies, the test groups showed significantly reduced CINV (RR = 0.65) with an absolute risk reduction of 24% compared to controls. They further divided test groups into an injection group and an oral administration group. Four different injection products were tested in six studies, with an overall RR of 0.73 in the traditional medicine plus oxaliplatin group. In the oral administration, 21 studies were analyzed, which contained 98 different plant-based ingredients with an average of 12 ingredients per traditional medicine intervention. The oral agents demonstrated an overall reduction in CINV with a RR of 0.62. The absolute risk reduction was 25% for the test groups compared to controls. In addition, each plant was analyzed individually as well as in all combinations (2, 3, 4, 5, 6, and 7 plants). The results demonstrated that six plants influenced the relative risk for CINV, including atractylodes, poria, coix, glycyrrhiza, astragalus, and panax ginseng.

Conclusions

This meta-analysis of 27 studies suggested the potential benefit of adding traditional medicines in the reduction of CINV associated with oxaliplatin-based chemotherapy in adults with colorectal cancer. The lack of blinding in most studies may have led to an overestimation of the effects on CINV. Sensitivity analysis identified six plants that were associated with significant reductions in CINV, which may warrant further clinical research.

Limitations

  • No quality evaluation
  • Low sample sizes
  • Most studies were not blinded and did not have a placebo for the control groups, which is likely to influence participant-reported CINV. The use of antiemetics also may have affected study results. No dosing information on treatment regimens were used other than the inclusion of oxaliplatin. Most studies were small single institutions studies, and the methodological reporting of the quality of studies and randomization was weak.

Nursing Implications

In this meta-analysis of traditional medicine interventions in adult patients with colorectal cancer receiving oxaliplatin-based therapies, six plants demonstrated reductions in CINV. Although the studies had limitations related to methodology, no serious adverse events or increase in CINV occurred. These plants warrant further research and consideration in patients whose CINV is not well-controlled by conventional therapies.

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Chen, T.H., Tung, T.H., Chen, P.S., Wang, S.H., Chao, C.M., Hsiung, N.H., & Chi, C.C. (2016). The clinical effects of aromatherapy massage on reducing pain for the cancer patients: Meta-analysis of randomized controlled trials. Evidence-Based Complementary and Alternative Medicine, 2016, 9147974.

Purpose

STUDY PURPOSE: To investigate the effectiveness of massage in reducing cancer-related pain

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PubMed and Cochrane Collaboration
 
INCLUSION CRITERIA: Randomized, controlled trial, comparison of massage with essential oils to a no-massage control group.
 
EXCLUSION CRITERIA: None specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 63
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane collaboration risk of bias assessment. Mixed findings for risk of bias

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 3
  • TOTAL PATIENTS INCLUDED IN REVIEW = 278
  • SAMPLE RANGE ACROSS STUDIES: 14–115 patients
  • KEY SAMPLE CHARACTERISTICS: No details were provided.

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable
 
APPLICATIONS: Palliative care

Results

The pooled standard mean difference was 0.01, showing no effect of aromatherapy massage compared to usual care for reduction in pain.

Conclusions

Findings do not show that aromatherapy massage is effective in reducing pain.

Limitations

  • Limited search
  • Limited number of studies included
  • Low sample sizes

Nursing Implications

Overall, mixed evidence existed regarding effects of massage therapies for pain management among patients with cancer. This analysis did not show effectiveness of aromatherapy massage, but was very limited by the small number of studies included and small study samples. Massage is a low-risk intervention that may be beneficial for some patients.

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Chen, H.M., Tsai, C.M., Wu, Y.C., Lin, K.C., & Lin, C.C. (2016). Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: A randomised controlled trial. British Journal of Cancer, 115, 1304–1312.

Study Purpose

To assess the effects of a 12-week walking program on improving subjective and objective sleep quality and rest-activity rhythms in patients with lung cancer

Intervention Characteristics/Basic Study Process

Home-based walking exercise at moderate intensity and weekly exercise counseling were provided. Participants were given detailed instruction according to a manual for the exercise program, including determination of intensity, pulse monitoring, rating perceived exertion, prevention of injury, and conditions requiring termination of the exercise program. Weekly exercise-related phone counseling was provided to reinforce teaching and encourage continued participation. The usual care control group was given typical services and asked to maintain normal activity and not perform additional exercise. Exercise counseling was offered to the usual care group at the end of the study. An actigraph was worn by patients to collect data continuously for 72 hours.

Sample Characteristics

  • N = 111, 89 assessed at six months
  • MEAN AGE = 63.6 years
  • AGE RANGE = 37–83 years
  • MALES: 44.1%, FEMALES: 55.9%
  • CURRENT TREATMENT: Combination radiation and chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: All had surgery for lung cancer, and most were receiving radiation and chemotherapy. Most had stage I disease.
  • OTHER KEY SAMPLE CHARACTERISTICS: Eighty-two percent were married. Patients were an average of 454 days since diagnosis.

Setting

  • SITE: Single-site   
  • SETTING TYPE: Home    
  • LOCATION: Taiwan

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Pittsburgh Sleep Quality Index (PSQI)
  • Actigraphy for evaluation of rest activity parameters, sleep parameters, and physical activity

Results

Overall participants completed 58.2% of all planned exercise sessions. The usual care group showed a higher mean amount of moderate physical activity at all time points when measured (37–46 minutes per day compared to 38–10 minutes per day at three and six months). No significant difference over time was reported between groups. The walking exercise group had improved PSQI scores over time compared to the usual care group (p = 0.001). No differences between groups in objective measures of sleep quality existed, except that total sleep time at six months was higher in the exercise group (p = 0.023).

Conclusions

Sleep quality measures showed improvement in the study group compared to the controls; however, given that the average amount of moderate intensity exercise was higher in the control group, the impact of walking exercise versus counseling is unclear.

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
  • Measurement/methods not well described
  • Subject withdrawals ≥ 10%
  • It was stated that baseline minutes of moderate activity differed significantly between study groups; however, data were not provided, and the direction of difference is unknown.
 

 

Nursing Implications

The effect of exercise on sleep quality in patients with insomnia remains unclear from this study. Although measures showed improvement in the walking exercise group compared to the controls, the amount of moderate intensity exercise was actually higher in the control group. This does not point to the impact of exercise on differences seen in this study.

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Chemaly, R.F., Sharma, P.S., Youssef, S., Gerber, D., Hwu, P., Hanmod, S.S., . . . Raad, I.I. (2010). The efficacy of catheters coated with minocycline and rifampin in the prevention of catheter-related bacteremia in cancer patients receiving high-dose interleukin-2. International Journal of Infectious Diseases, 14, e548–e552.

Study Purpose

The purpose of this study was to evaluate effects of antibiotic-coated central venous catheters as compared to non-coated central venous catheters on the development of catheter-associated blood stream infection.

Intervention Characteristics/Basic Study Process

Data was retrospectively analyzed from December 1, 2003 through August 31, 2006 at an inpatient center for patients treated with interleukin-2. Prior to December 2004, non-coated tunneled catheters (NC-C)  were used in these patients; antibiotic-coated catheters were used after December 2004. The coated catheters contained minocycline and rifampin (M/R-C) in their coating. All patients received antibiotic prophylaxis. Cases of catheter-related infection were retrospectively analyzed and compared between the two groups. Catheter insertion and line care remained the same for both groups independent of the type of catheter inserted.

Sample Characteristics

  • The study reviewed 78 and 107 episodes of catheter use.
  • The age range of studied participants was 26–66 years.
  • Sixty-one percent of reviewed participants were diagnosed with melanoma and renal cell carcinoma.
  • Non-coated catheters were used in 77 episodes, and M/R-C-coated catheters were used in 30 episodes. All patients received IV nafcillin (67%), clindamycin (15%), or levofloxacin (13%) during high-dose interleukin-2 for 48 hours afterwards.

Setting

A single-site inpatient setting.

Phase of Care and Clinical Applications

Active treatment

Study Design

Retrospective descriptive

Measurement Instruments/Methods

  • Catheter colonization was defined as the isolation of 15 colony-forming units (CFU) of any microorganism from a catheter tip or subcutaneous segment; or any organism from a blood culture drawn through the catheter during routine surveillance in the absence of fever.
  • Local catheter-related infection was defined as exit site infection as demonstrated by purulent drainage from the catheter site.
  • Probable catheter-related bacteremia (CRB) was defined as the presence of an indwelling central venous catheter (CVC) with at least one positive blood culture from the peripheral vein, with clinical manifestations of infection.
  • Definite CRB was defined as the presence of an indwelling CVC with at least one positive blood culture from the peripheral vein, manifestations of infection, and no apparent source for the blood stream infection except the catheter. Response to treatment was defined as the resolution of all clinical and microbiological manifestations of catheter-related infection, and failure to treatment was defined as persistence of the clinical signs and symptoms of the infection and positive microbiological data.
     

Results

A total of nine episodes of CRB were identified (six were probable and three definite), all in patients with NC-C (M/R-C 0% versus NC-C 12%; p = 0.06). In three of the nine episodes of bacteremia, the blood cultures grew more than one pathogen and in all nine cases, the prophylactic antibiotic had no activity against the pathogen. The causative pathogens for CRB included methicillin-resistant, coagulase-negative infections. There was one episode of probable catheter-related candidemia (Candidaparapsilosis) in a patient with a coated catheter, while two episodes of catheter colonization secondary to coagulase-negative Staphylococci occurred in two patients who had no signs or symptoms of infection.

Conclusions

Based on the data presented, there is potential benefit to an antibiotic-coated catheter compared with a non-coated catheter.

Limitations

  • Small sample (less than 100 participants)
  • Only 30 cases with coated catheters
  • Retrospective design

Nursing Implications

No recommendations can be made on the basis of this study alone. Antibiotic-coated, short-term CVCs may be helpful in preventing catheter-associated bloodstream infections.

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Cheema, B., Gaul, C.A., Lane, K., & Fiatarone Singh, M.A. (2008). Progressive resistance training in breast cancer: A systematic review of clinical trials. Breast Cancer Research and Treatment, 109(1), 9–26.

Purpose

To systematically review studies that have prescribed progressive resistance training (PRT) in breast cancer

Search Strategy

Databases searched were PubMed, Medline, CINAHL, SportDiscus, Embase, and Web of Science. Search keywords were breast cancer, oncology, malignancy, neoplasm, tumor, mastectomy, lumpectomy, radiotherapy, chemotherapy, and exercise training, training, physical activity, rehabilitation, resistance training, aerobic training, strength training, lifestyle, muscle, endurance, and strength. Studies were included if they

  • Had a patient population of adults aged 18 years or older diagnosed and surgically treated for malignancy of the breast
  • Prescribed PRT in isolation or in combination with other exercise modalities (e.g., aerobic training) after breast cancer surgery, adjuvant therapies (i.e., radiotherapy or chemotherapy), or any other time after breast cancer treatment
  • Evaluated outcomes potentially responsive to chronic PRT, including a broad spectrum of physiological, functional, and psychological outcome measures.

Studies were excluded if they investigated the effects of single, acute bouts of PRT, prescribed movement exercises without loading against a resistance, or prescribed PRT before breast cancer treatment.
 

Literature Evaluated

The total number of studies initially reviewed was 12. The Delphi List was used as the method of study evaluation.
 

Sample Characteristics

  • The number of studies included in the report was 10.
  • The total sample size across studies was 538, with a range of less than 20 to 242.
  • Patients were female and being treated for breast cancer stages 0–III.
  • Some patients had lymphedema.
  • Patient age ranged from 25–78 years.
  • Most patients were post-menopausal.
  • The majority of patients received intervention after chemotherapy or radiation.

Results

The study included a broad spectrum of physiological (body compositions, including reduced sum of five skinfolds, reduced waist and hip circumferences, reduced percent body fat, and increased muscle mass) , functional (improved upper-body strength, increased upper-body muscular endurance, increased flexibility of the ipsilateral (surgical) and contralateral shoulder joint, and improvements of lower-body strength) and psychological (improved aspects of quality of life, depression, and mood) outcome measures. Lymphedema incidence secondary to exercise programs was tracked as an adverse event in six studies. There was no incidence or exacerbation of lymphedema or improvements in lymphedema attributed to the exercise regimens.

Conclusions

Women surgically treated for breast cancer can derive health-related and clinical benefits by performing PRT after breast cancer surgery. No exacerbation or improvement of objectively measured or subjectively reported lymphedema symptoms were reported.

Nursing Implications

PRT should be advocated among oncologists and in community care settings.

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Cheema, B.S., Kilbreath, S.L., Fahey, P.P., Delaney, G.P., & Atlantis, E. (2014). Safety and efficacy of progressive resistance training in breast cancer: A systematic review and meta-analysis. Breast Cancer Research and Treatment, 148, 249–268. 

Purpose

STUDY PURPOSE: To assess the safety and efficacy of progressive resistance training in patients with breast cancer with attention to effects on lymphedema

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, PubMed, Science direct, SPORT-discus, Scopus, Embase, Cinahl, and the Cochrane Library
 
KEYWORDS: Extensive sample search terms are provided; syntaxes were developed including terms for breast cancer, resistance training, weight training, and strength training
 
INCLUSION CRITERIA: Studies examining the isolated effects of resistance training (PRT) on breast cancer-related lymphedema, strength, or quality of life; intervention duration of at least six weeks
 
EXCLUSION CRITERIA: Use of aerobic training along with PRT unless the comparison group had the same dosage of aerobic training

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 446
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A quality checklist was developed and used to score areas of randomization and blinding, the similarity of groups at baseline, eligibility specification, compliance reporting, supervision of the intervention, dropout reporting, data reported, adverse event reporting, and an intent to treat analysis

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 15
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,652
  • SAMPLE RANGE ACROSS STUDIES: 21–232 patients
  • KEY SAMPLE CHARACTERISTICS: Mean age ranged from 26–62 years

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results

For the five studies included in the meta-analysis (654 patients), the odds ratio for the incidence or exacerbation of lymphedema was 0.53 (95%, CI = 0.31–0.9). PRT did not change arm volume or patient-reported severity as shown by an analysis of standard mean differences. Five studies reported no adverse events, and other studies reported temporary muscle soreness or minor musculoskeletal injuries. There was no significant heterogeneity. PRT produced a small, nonsignificant improvement in quality of life (SMD = 0.17). Overall, PRT improved upper and lower body muscle strength. Ten studies used machines or free weights for training.

Conclusions

Progressive resistance training did not induce or exacerbate arm lymphedema in women with breast cancer, and it was not associated with any severe adverse events.

Limitations

Some included studies were done in women without lymphedema, and the risk of development was not clear from data in this review.

Nursing Implications

The findings of this meta-analysis suggested that progressive resistance training is safe in women with breast cancer and does not induce or exacerbate arm lymphedema. Women do not need to avoid lifting weight to prevent the exacerbation of lymphedema.

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Chay, WY., Tan, SH., Lo, YL, Ong, S.Y., Ng., H.C., Gao, F., . . . Choo, S.P. (2010). Use of calcium and magnesium infusions in prevention of oxaliplatin induced sensory neuropathy. Asia Pacific Journal of Clinical Oncology, 6, 270–277.

Study Purpose

The purpose of the study was to evaluate the neuropathy-protective effects of calcium and magnesium infusions in patients receiving oxaliplatin.

Intervention Characteristics/Basic Study Process

Patients were randomized to a treatment group with calcium gluconate 1 g plus 1 g of magnesium sulfate in 100 ml normal saline infused before and after oxaliplatin, or a placebo group with infusions of normal saline.

Sample Characteristics

  • The sample consisted of 19 participants with a mean age of 54 years.
  • The amount of men (52%) slightly outnumbered the amount of women (48%).
  • All of the participants had colorectal cancer and were receiving oxaliplatin-based chemotherapy with a life expectancy of more than three months.
  • Exclusion criteria included previous treatment with platinum-based chemotherapy and/or a preexisting neurologic disease or metastases.
  • Seventy-eight percent of the patients received 600 mg/m² of oxaliplatin.
  • The median follow-up was 8.7 months.

Setting

The study was conducted in a single-site location in Singapore.

Phase of Care and Clinical Applications

  • Active treatment
  • Late effects

Study Design

The study was a blinded, placebo-controlled, randomized phase II design.

Measurement Instruments/Methods

Measurements included the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0] and oxaliplatin-specific toxicity scale nerve conduction studies.

Results

Incidence of grade 1 and 2 neurotoxicity was higher in the placebo group, but there was a higher proportion of grade 3 cumulative numbness in the treatment group. No differences were noted between groups for tingling and cold sensitivity. In addition, no difference was noted in time to onset of symptoms. Conduction studies showed lower median score at the end of the study in the treatment arm (p = 0.02). Of note, the study was ended prematurely.

Conclusions

This study does not provide strong evidence regarding the efficacy of calcium and magnesium infusion for the reduction of chemotherapy-associated peripheral neuropathy.

Limitations

  • A small sample size (less than 30 participants).
  • Findings and reported conclusions can be confusing since median end of study nerve conduction scores suggested increased abnormal conduction in the treatment group, as noted by the authors.
  • A correlation between nerve conduction findings and subjective patient symptoms are unclear.
  • No information was provided regarding chemotherapy treatment delays or dose reductions.
  • Given the question of cumulative effects, it may be more useful to look at symptoms at oxaliplatin dose levels rather than time.

Nursing Implications

Because of a small sample size, this current study does not provide strong evidence regarding use of calcium and magnesium infusions. Neuropathic symptom effects appear to be mixed, with higher prevalence of grade 3 with treatment, but overall prevalence lower with treatment. Some symptoms appear to be affected and some do not, and the relationship between nerve conduction findings and symptoms are unclear. Additional research in this area is needed to clarify the actual impact of calcium and magnesium for protective effects with neurotoxic treatment.

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Chasen, M., Urban, L., Schnadig, I., Rapoport, B., Powers, D., Arora, S., . . . Gridelli, C. (2017). Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. Supportive Care in Cancer, 25, 85–92. 

Study Purpose

To assess the impact of adding rolapitant to standard antiemetics (5-HT3 receptor antagonists and dexamethasone) on the daily lives of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC)

Intervention Characteristics/Basic Study Process

This is a secondary analysis study of three clinical trials (phase III experimental studies). Patients were stratified by sex and randomly assigned (1:1) to either single oral dose rolapitant 180 mg or placebo 1–2 hours prior to chemotherapy. All patients received 5-HT3 receptor antagonists and dexamethasone. Quality of life was assessed by patients by completing the 18-item Functional Living Index-Emesis (FLI-E) questionnaire on day 6 of cycle 1.

Sample Characteristics

  • N = 2,402 (1,070 patients in the pooled HEC studies and 1,332 patients in the MEC/AC)   
  • AGE: Between 18–90 years
  • MALES: 39.1% (938 patients), FEMALES: 60.9% (1,464 patients)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Various malignancies; a Karnofsky performance score of 60 or greater; a predicted life expectancy of four months or greater; and adequate bone marrow, kidney, and liver function
  • OTHER KEY SAMPLE CHARACTERISTICS: Aged older than 18 years, naïve to their scheduled HEC/MEC

Setting

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

Phase of Care and Clinical Applications

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

Study Design

Three double-blind, phase III, randomized, controlled longitudinal trials (specified analyses [MEC/AC study]), and pooled post hoc analyses (HEC studies)

Measurement Instruments/Methods

Treatment comparisons were performed between the FLI-E questionnaire total score and nausea and vomiting domain scores, in addition to the end point of no impact on daily life.

Results

Data were analyzed for all randomized patients in the modified intent-to-treat population. Patients in the rolapitant group reported a significantly higher FLI-E total score than patients in the control group in the pooled HEC studies (confidence interval [CI] [2.6, 7.9], p < 0.001) and in the MEC/AC study (CI [1.7, 6.5], p < 0.001). A significant improvement in the nausea domain score was observed with rolapitant versus control in the pooled HEC studies (CI [0.2, 3.4], p = 0.02) and the MEC/AC study (CI [0.3, 3.3], p = 0.019), as well as the vomiting domain score in the pooled HEC studies (CI [2.1, 4.7], p < 0.001) and the MEC/AC study (CI [1.1, 3.4], p < 0.001).

Conclusions

This secondary analysis study demonstrated the efficacy of adding rolapitant to standard antiemetics in reducing the negative delayed impact of CINV on the daily lives of patients receiving HEC or MEC.

Limitations

  • Baseline sample/group differences of import
  • Secondary analysis data from three experimental clinical trials
  • Included patient with various cancers

Nursing Implications

Nurses should be aware of the additional benefit of adding an NK1 receptor antagonist to the treatment of patients with cancer receiving HEC and MEC.

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