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Griffiths, C., Kwon, N., Beaumont, J.L., & Paice, J.A. (2018). Cold therapy to prevent paclitaxel-induced peripheral neuropathy. Supportive Care in Cancer, 26, 3461–3469.

Study Purpose

Evaluate the effectiveness of cold therapy on prevention of CIPN in those receiving paclitaxel-based therapy for breast cancer.

Intervention Characteristics/Basic Study Process

Patients wore glycerine-containing Elasto-Gel glove and sock on one extremity and nothing on the other extremity. Elasto-Gel glove/sock were cooled to -25 to -30 C in a freezer for at least three hours prior to administration; was worn for a total of 210 minutes, and changed every 45-50 minutes during infusion. A total of nine data points were collected.

Sample Characteristics

  • N = 33 enrolled; 29 evaluable at time point 1; 7 evaluable at time point 6; study terminated after time point 6.  
  • AGE: 47.3 years (range = 35-68)
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All patients had breast cancer; adjuvant therapy in 62%; neoadjuvant therapy in 38%.
  • OTHER KEY SAMPLE CHARACTERISTICS: 55% married; 31% single; 14% divorced; 88% nonsmoker; 8% current active smoker; 4% quit smoking. BMI average 28.5 (17.5 to 44.4).

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Robert H. Lurie Comprehensive Cancer Center

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized controlled study of taxane-naïve patients receiving dose dense anthracycline plus paclitaxel therapy. Patients were own paired control.

Measurement Instruments/Methods

Symptoms of neuropathic pain, including pain severity and sensory severity. Measured with NPSI, BPI, and QST for measurement of pain, pain severity, and sensory severity, respectively).

Results

No significant difference in pain as measured by NPSI; all measurements of pain severity were increased with the BPI, including interference with daily activity, worst pain in the last 24 hours, average pain in 24 hours, and pain currently experienced. No significant difference in any of the five QSTs used for sensory severity, including sensitivity to innocuous touch, sensitivity to noxious stimuli, sensitivity to vibration, manual dexterity, and fine motor dexterity.

Conclusions

Study was stopped early at time point 6 due to high dropout rate from discomfort related to intervention; when stopped, no evidence of decreased CIPN was seen.

Limitations

  • Small sample (< 30)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Sample characteristics include patients with only one disease and one type of therapy. Intervention would require significant buy-in from institution as it would require freezers in location of therapy and would require nursing or other staff to change glove/sock every 45-50 minutes.

Nursing Implications

Education about current therapies. Further research needed on cryotherapy for prevention of CIPN.

Print

Han, X., Wang, L., Shi, H., Zheng, G., He, J., Wu, W., . . . Wei, G. (2017). Acupuncture combined with methylcobalamin for the treatment of chemotherapy-induced peripheral neuropathy in patients with multiple myeloma. BMC Cancer, 17, 40.

Study Purpose

To investigate if acupuncture plus methlycobalamin is an effective treatment compared to methlycobalamin alone in reducing CIPN in patients with multiple myeloma.

Intervention Characteristics/Basic Study Process

Acupuncture plus methylcobalamin (Met + Acu) was compared with methylcobalamin alone to evaluate effectiveness on CIPN as measured by VAS, FACT-GOG-NTX (functional assessment of neurotoxicity) and nerve conduction velocity compared to methlycobalamin (Met) alone in patients with multiple myeloma.

Patients with multiple myeloma randomized to treatment group (Met+Acu) or control group (Met). Intervention duration for both groups was 84 days
                                               
Methylcobalamin administration protocol x 3 cycles/84 days: 1 cycle = 500 mcg IM qod x 20 days(10 injections) then two months oral met 500 mcg tid                                                                                                                                                                                           

Acu administration of protocol x 3 cycles: 1 cycle = bilateral acupuncture needles at designated acupoints (aseptic adm by senior physician (15 years of experience) at depth 0.3-1 inches x 30 minutes; initially in prone position with needle retention then administered to same acupoints in supine position x 3 days then qod x 10 days

Sample Characteristics

  • N = 98  (49 in treatment, 49 in control group) 
  • AGE: Mean = 64 years
  • MALES: 57%  
  • FEMALES: 43%
  • CURRENT TREATMENT: Chemotherapy, combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Multiple myeloma: subtypes IgG, IgA, IgD, light chain (kappa/lamda)
  • OTHER KEY SAMPLE CHARACTERISTICS: Baseline EMG showed impairment of median and peroneal nerve conduction, no central nervous system or other disease related preexisting peripheral neuropathy, no pre-chemo peripheral neuropathy; baseline PN occurring after initiation of chemotherapy assessed by NCI-CTCAE at grade 2-4; baseline VAS 5.5-5.57/10; baseline FACT/GOG-NTX scores 36.48-36.63; no significant differences in baseline characteristics between treatment and control group.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Multiple Myeloma Center, Bone Marrow Transplantation Center, Department of Hematology: The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China

Phase of Care and Clinical Applications

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

Study Design

Prospective randomized controlled trial to investigate effect of Met + Acu versus Met on CIPN, sx neurotoxicity and nerve conduction

Measurement Instruments/Methods

VAS pain score (neuropathic pain); FACT/GOG-NTX questionnaire (functional assessment of neurotoxicity); EMG (nerve conduction velocity)

Results

Evaluated outcome measures before and after treatments within and between Met + Acu and Met groups:

  • VAS decreased in both Met + Acu and Met group (p < 0.001); Significant decrease VAS in Met + Acu compared to Met control group (p < 0.01)
  • FACT/GOG-Ntx scores significant improvement within Met + Acu group (p < 0.001) and between Met + Acu group compared to Met control group (p < 0.05)
  • Nerve conduction velocity: Motor conduction velocity significant improvement in Met + Acu group of bilateral median (p < 0.05) and peroneal nerves (p < 0.01); sensory conduction velocity showed significant improvement within Met + Acu group and between Met + Acu and Met control group of only sural nerve (p < 0.01); No improvement in FACT/GOG-NTX scores or in nerve conduction velocity in Met control group.

Conclusions

In 98 patients with multiple myeloma with grade 2 or higher CIPN, there was significant reduction in PN pain in Met + Acu and Met groups but more significant relief with Met + Acu. Only Met + Acu group had significant improvement in functional assessment of neurotoxicity symptoms and nerve conduction; no improvement in Met control group

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no appropriate attentional control condition) 
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement/methods not well described
  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Other limitations/explanation: CIPN grade using NCI-CTCAE was not re-evaluated after baseline; CIPN severity assessment not reported and used a different grading system than baseline; randomization procedures not explained; sampling methods not described, uncertain whether VAS was specific to neuropathic pain in the hands/feet or general pain; FACT/GOG-NTX instrument validated for platinum/paclitaxel-induced peripheral neuropathy, and findings of specific categories of FACT/GOG-NTX not reported; only combined scores (this instrument measures peripheral neuropathy on multiple dimensions physical, social, emotional, functional, neurotoxicity sx); Actual p values not reported; no effect size reported; a two-way ANOVA should have been used to compare within- and between-group differences, an independent sample t test was used for the same group when a paired t test should have been used; prior/current treatment regimens of sample not identified to determine distinct pharmacologic origin of CIPN; not specified if patients actively receiving treatment or off treatment or time from last treatment; analgesics/neuroleptics/other CIPN treatments prior to or during study not identified, prior acupuncture (i.e., contamination) not identified

Nursing Implications

Acupuncture plus methylcobalamin may relieve CIPN-related pain, function, and nerve conduction in patients with multiple myeloma. Large multi-center, randomized controledl trials are needed to validate these findings and investigate their effects related to pharmacotherapies specific to MM utilizing rigorous measurement tools and validated instruments specific to patients with MM.

Print

Noh, H., Yoon, S.W., & Park, B. (2018). A systematic review of herbal medicine for chemotherapy induced peripheral neuropathy. Evidence-Based Complementary and Alternative Medicine, 2018, 6194184.

Purpose

STUDY PURPOSE: To evaluate the evidence related to use of herbal medicine for prevention and treatment of chemotherapy-induced peripheral neuropathy

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: 13 electronic databases including Medline, CENTRAL, EMBASE, AMED, China National Knowledge Infrastructure, Wanfang Database, CQVIP database, Korean Studies Information, DBPIA, Korea Institute of Science Technology Information, Research Information Center for Health Database, Korean Traditional Knowledge Portal, KoreaMed

YEARS INCLUDED: (Overall for all databases) through May 2017, no other limitations on publication date

INCLUSION CRITERIA: Randomized controlled trials that tested herbal medicine for preventing or treating CIPN. Participants in the studies were at least 18 years old, diagnosed with cancer, had received chemotherapy, and had CIPN diagnosed by clinical assessment.

EXCLUSION CRITERIA: Only the first treatment period data was analyzed for crossover trials. If the authors could not separate the results of the first and second periods in the crossover trial, they excluded the study. RCTs with unreliable or unavailable methods or results

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 819

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 28

TOTAL PATIENTS INCLUDED IN REVIEW: 2,174

SAMPLE RANGE ACROSS STUDIES: 31-186

KEY SAMPLE CHARACTERISTICS: Various solid tumors and one study in multiple myeloma, studies investigated oral herbals foot baths, IV, and fumigation. Oxaliplatin was used in 20 studies, paclitaxel was used in two, docetaxel was used in one, and various chemotherapy regimens were used in four studies.

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Results

The authors were unable to perform planned meta-analysis because of the heterogenicity of herbal treatments, doses, outcome measures, and small sample sizes.

Conclusions

Unable to draw any conclusions about the efficacy of herbal treatments for prevention or treatment of CIPN

Limitations

  • No quality evaluation
  • High heterogeneity
  • Low sample sizes

Nursing Implications

No changes to clinical practice can be recommended based on this article.

Print

Kuriyama, A., & Endo, K. (2018). Goshajinkigan for prevention of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Supportive Care in Cancer, 26, 1051–1059.

Purpose

STUDY PURPOSE: Examine whether goshajinkagin prevents CIPN in patients receiving neurotoxic chemotherapy.

TYPE OF STUDY: Meta analysis and systematic review

Search Strategy

DATABASES USED: PubMed, EMBASE, Ichushi, Cochrane Central Register of Controlled Trials

YEARS INCLUDED: (Overall for all databases) inception through August, 2017

INCLUSION CRITERIA: Randomized controlled trials that assessed efficacy and safety of goshajinkagin in preventing CIPN; patients had to be undergoing neurotoxic chemotherapy (taxanes, vinca alkaloids, platinum agents); adult patients older than age 18 years ; prophylactic doses of goshajinkagin (7.5 g per day)

EXCLUSION CRITERIA: Patients that had already developed CIPN; dosing of goshajinkagin that was given as treatment for CIPN rather than prophylaxis

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 234 articles retrieved; five articles evaluable after inclusion/exclusion applied

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Five trials with 397 total patients; 3 colon cancer, 2 breast cancer

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 5 

TOTAL PATIENTS INCLUDED IN REVIEW: 397

SAMPLE RANGE ACROSS STUDIES: Included patients with breast cancer or colon cancer, receiving FOLFOX 4 or FOLFOX 6, and weekly paclitaxel- or docetaxel-based chemotherapy. Studies ranged from 18-186 patients; studies ranged from 12-26 weeks in duration. Two trials with placebo comparator; two trials with no interventions for control; one trial administered mecobalamin for comparison; one trial terminated early due to incidence of increased CIPN. Two different definitions of CIPN used, those from NCI-CTCAE in four studies (measuring severity) and that from the Neurotoxicity Criteria of Debiopharm (DEB-NTC) in one study (measuring duration)

KEY SAMPLE CHARACTERISTICS: 35-88 years old; breast cancer and colon cancer

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Results

Overall, the use of goshajinkagin was not related to a decreased incidence of CIPN; though in the one study there was reduced incidence of grade 1 and grade 3 CIPN, but no difference in grade 2 CIPN. One study with increased incidence of CIPN (stopped early).

Conclusions

No evidence to support the use of goshajinkagin for prevention of CIPN.

Limitations

  • Limited number of studies included
  • High heterogeneity
  • Different criteria for grading of CIPN

Nursing Implications

Further research on use of the medication may be warranted. Education of patients about the inconsistent results.

Print

Hoshino, N., Ganeko, R., Hida, K., & Sakai, Y. (2018). Goshajinkigan for reducing chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. International Journal of Clinical Oncology, 23, 434–442.

Purpose

STUDY PURPOSE: To evaluate the efficacy and safety of Goshajinkigan for prevention of CIPN

TYPE OF STUDY: Meta analysis and systematic review

Search Strategy

DATABASES USED: SCOPUS, Ovid, Medline, Cochrane Central Register of Controlled Trials, ICHUSHI, Google Scholar 

YEARS INCLUDED: Not specified

INCLUSION CRITERIA: Randomized controlled trials, cluster-randomized, crossover, and quasi-randomized trials evaluating goshajinigan for CIPN; studies needed to include adult patients (aged 18 years or older) receiving hospital-based chemotherapy

EXCLUSION CRITERIA: Articles that did not meet this criteria

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,345 originally; 9 selected for full-text review; 5 included in the final analysis

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Potential biases were evaluated for each study using methods described in the Cochrane Handbook for Systematic Reviews of Interventions

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: 5

TOTAL PATIENTS INCLUDED IN REVIEW: 386

SAMPLE RANGE ACROSS STUDIES: 10-182

KEY SAMPLE CHARACTERISTICS: Three of the studies were in colorectal cancer and two in breast cancer; three focused on oxaliplatin, one on paclitaxel, and one on docetaxel; two studies did not include a comparison, two compared goshajinigan to placebo, and one compared goshajinigan to Vitamin B12

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Results

Goshajinkigan did not reduce the incidence of grade 2 or 3 CIPN in studies that reported CTCAE results.

The article reports trends toward decreased risk of developing grade 2 or 3 CIPN in studies using neurotoxicity criteria of debiopharm; however, these findings were not statistically significant. 

No severe adverse events seen with Goshajinkigan.

Goshajinkigan did not influence the response to chemotherapy.

Conclusions

This article does not provide evidence to support the use of Goshajinkigan for prevention of CIPN

Limitations

  • Limited number of studies included
  • Mostly low quality/high risk of bias studies   
  • High heterogeneity
  • Low sample sizes

Nursing Implications

Based on this meta-analysis, Goshajinkigan should not be recommended to patients. Further study, using rigorous, randomized, double blinded methods and large sample sizes are needed.

Print

Kleckner, I.R., Kamen, C., Gewandter, J.S., Mohile, N.A., Heckler, C.E., Culakova, E., . . . Mustian, K.M. (2018). Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: A multicenter, randomized controlled trial. Supportive Care in Cancer, 26, 1019–1028.

Study Purpose

To explore the effect of a moderate-intensity, home-based, six-week progressive walking and resistance exercise program on chemotherapy-induced peripheral neuropathy (CIPN) symptoms, and factors that predict CIPN and moderate the effects of exercise on CIPN, in patients with cancer receiving taxane-, platinum-, or vinca alkaloid-based chemotherapy, compared to standard of care.

Intervention Characteristics/Basic Study Process

Control condition: Standard care wait list control. Received the same number of follow-up visits as the exercise group.

Exercise for Cancer Patients (EXCAP) intervention: Moderate-intensity, home-based, six-week progressive walking and resistance exercise program developed by the American College of Sports Medicine.

  • Walking dose: Low/moderate-intensity (60%-85% heart rate reserve) daily. Tailored based on individual’s baseline steps per day; increase steps per day by 5%-20% each week
  • Resistance training dose: Theraband (resistance at 3-5 rating of perceived exertion [RPE]) daily. Ten required and four optional upper and lower extremity exercises (e.g., squats, biceps curl). Tailored progression up to four sets of 15 reps and in theraband resistance each week 
  • Duration: Six weeks
  • Materials provided to the patient: Pedometer, three resistance bands, and manual
  • Visits: One 60-minute intervention orientation session in the clinic on the patient’s first day of chemotherapy
  • Interventionist: Clinical research associates who had no professional exercise qualifications but received brief training in the EXCAP by an ACSM-certified exercise professional

Sample Characteristics

  • N = 355   
  • AGE: Mean age = 55.8 years (SD = 10.8; range = 28-79 years)
  • MALES: 7.32%  
  • FEMALES: 92.68%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Stages I-IV of primarily breast (79%) but also lymphoma, colon, lung, and other types of cancer; receiving taxanes (61.4%), platinums (11%), and/or vinca alkaloids (5%), but chemotherapy naïve at baseline. Mean baseline neuropathy on 0-10 NRS was 0.9 (SD = 1.9) (numbness and tingling) and 0.8 (SD = 1.9) (hot/coldness in hands/feet); 29.6% of patients reported any numbness and tingling in hands/feet.
  • OTHER KEY SAMPLE CHARACTERISTICS: Inactive (in precontemplation, contemplation, or preparation per the Exercise Stages of Change) at baseline. Karnofsky performance status ≥ 70% (mean = 94.6, SD = 7); 85.91% received prior surgery; less than 3% received XRT and/or hormone therapy; 67% were employed and 64.22% were married.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Home    
  • LOCATION: James P. Wilmot Cancer Center at University of Rochester Medical Center, NY, and 20 NCORP community oncology practice sites throughout the United States.

Phase of Care and Clinical Applications

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

Study Design

Secondary data analysis of a multi-site non-blinded randomized controlled trial (originally designed to evaluate the effects of the intervention on fatigue)

Measurement Instruments/Methods

Collected at baseline and after the intervention (at six weeks):

  • CIPN symptoms: 0-10 NRS of (a) numbness/tingling, and (b) hot/coldness in hands/feet in the past seven days
  • Exercise adherence: Daily exercise diary self-reported pedometer steps, minutes of resistance exercise, and RPE rated on 1-10 scale

Results

CIPN symptoms (NRS) progressed in both groups throughout chemotherapy (all p ≤ 0.027). However, NRS of numbness/tingling (p = 0.061; β = 0.42, CI [-0.85, 0.02]) and hotness/coldness in the hands/feet (p = 0.045; β = -0.46; CI [-0.01, -0.91]) were less severe in the intervention group at six weeks; 36.5% of intervention group participants and 49.2% of control group participants reported some numbness/tingling (NRS > 0) at six weeks. 

Baseline neuropathy (NRS), female sex, and non-breast cancer predicted greater increase in CIPN (p < 0.05). Male participants responded better to the exercise intervention than female participants (p = 0.028)

Intervention group participants increased their mean daily steps by 649 (0.32 mi) to a mean of 4,820 steps per day, and the control group participants decreased in daily steps to 4,285 steps per day. The intervention participants’ steps per day were significantly higher than the control group’s at six weeks (p = 0.019). Intervention participants performed significantly more days of resistance band exercise (~ 3.5 days per week) than controls (p < 0.001).

Conclusions

This study provides preliminary evidence, suggesting that progressive light/moderate-intensity walking (prescribed based on step counts) and elastic band resistance training daily may reduce CIPN progression during the first six weeks of neurotoxic chemotherapy treatment.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Selective outcomes reporting
  • Measurement/methods not well described
  • Measurement validity/reliability questionable
  • Subject withdrawals ≥ 10%  
  • Other limitations/explanation: Secondary analysis originally aimed to evaluate effects of exercise intervention on physical activity, fatigue, cognitive impairment, and inflammation in 619 patients receiving chemothearpy. Although the 0-10 NRS is a gold-standard measure of pain, its one-item validity and reliability in measuring CIPN is questionable. No control/stratification for comorbidities that could influence CIPN, such as diabetes and the type and cumulative dose of neurotoxic chemotherapy received. Participants who withdrew from the study were older, and had greater fatigue and a lower education level at baseline (all p ≤ 0.019). More participants in exercise group withdrew compared to control group participants (p = 0.01). Questionable interpretation of the results; the authors frequently described the results as significant when the p was > 0.05 (their two-tailed significance α).

Nursing Implications

Light/moderate-intensity aerobic and strength training exercise is safe and may be beneficial for reducing CIPN in individuals receiving chemotherapy treatment; however, further research is needed to rigorously test the effect of various dosages of specific types of exercise on CIPN and evaluate the most feasible interventions that result in maximum adherence.

Print

Duregon, F., Vendramin, B., Bullo, V., Gobbo, S., Cugusi, L., Di Blasio, A., . . . Ermolao, A. (2018). Effects of exercise on cancer patients suffering chemotherapy-induced peripheral neuropathy undergoing treatment: A systematic review. Critical Reviews in Oncology/Hematology, 121, 90–100.

Purpose

STUDY PURPOSE: To evaluate current research evidence for exercise protocols effect on CIPN symptoms, balance control, physical function, and QOL

TYPE OF STUDY: Systematic review (no meta-analysis conducted)

Search Strategy

DATABASES USED: Medline, Scopus, Bandolier, PEDpro, and Web of Science

YEARS INCLUDED: (Overall for all databases) This was not specified

INCLUSION CRITERIA: Studies that had physical exercise intervention and QOL or a balance evaluation, structured exercise protocol for patients with cancer with CIPN was preferable, English peer-reviewed and indexed manuscripts, comparisons of pre-/postintervention of cancer diagnosis, one or both genders, and all races/ages. 

EXCLUSION CRITERIA: Cross-sectional studies, case reports, published abstracts, dissertation materials, conference presentations

Literature Evaluated

TOTAL REFERENCES RETRIEVED: N = 2221

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Literature search was clearly outlined but did not use standardized methodology (i.e., PRISMA); two reviewers independently examined abstracts, full manuscripts analyzed for eligibility and independently used the modified Cochrane Collaboration Back Review Group checklist to evaluate quality of studies on nine criteria and strength of evidence; high quality was determined if study met at least 5 out of 9 criteria, low quality was less than 5 out of 9; final quality score discussed between both reviewers for final determination of quality score, third researcher consulted for any discrepancies; extraction of data based on categorization for this study outcomes: CIPN symptoms, static balance control, dynamic balance control and quality of life and physical function

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: N (studies) = 5 (2 of 5 were randomized studies, of high quality, three non-randomized and low quality) 

TOTAL PATIENTS INCLUDED IN REVIEW: 147 (25 dropouts) (n = 122)

SAMPLE RANGE ACROSS STUDIES: 14-56 years

KEY SAMPLE CHARACTERISTICS: All participants with a diagnosis of malignancy; all had peripheral neuropathy before starting the intervention; age range = 44-71.82 years (one study of older adults, four studies of mid adult); 84 females and 63 males; 131 participants were undergoing chemotherapy out of 147 before dropouts. In three studies, 100% of participants were actively undergoing chemotherapy; in two studies, 54% of participants were undergoing chemotherapy. Three studies evaluated CIPN supervised training intervention and two studies evaluated home-based intervention. Exercise types included aerobic walking/cycling, strength/elastic band training, calisthenics, core stability, sensory motor, and specific balance training alone or in combination. Exercise dosages ranged from 30 to 60 minutes per sessions, two to five times per week, for 3 to 36 weeks.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Elder care; palliative care

Results

Three of four studies showed some modest improvement in CIPN with exercise; some small improvements found with exercise for static balance in all four studies; dynamic balance control evaluated in two studies, only one showed improvement with exercise; three of four studies showed improvements in QOL.

Conclusions

This systematic review of a small sample of five studies showed varying exercise interventions, with differing dose and duration of therapy, enhanced QOL and improved balance. However, this evidence synthesis is scant and drawing conclusions for practice would be premature as the majority of studies are of low quality. This systematic review highlights that more research is needed to determine specific exercise interventions targeted to specific cancer populations to understand the full benefit of exercise as an intervention strategy to reduce CIPN symptoms and related quality-of-life issues.

Limitations

  • Limited search
  • Limited number of studies included
  • Mostly low-quality/high-risk-of-bias studies
  • High heterogeneity
  • Low sample sizes

Other: poor choice and limited list of key terms in search strategy; literature search strategy and inclusion criteria did not specify year of studies, CIPN symptom outcome was not an inclusion criteria; study design and methodologies differed, control conditions of studies not adequately explained; different exercise interventions and time frames, different instruments across studies for outcome measures, including CIPN six, static/dynamic balance control, and QOL, some data does not fully represent the construct/categorization of study outcome measures. One study measured fear of falling substituting this as a QOL measure; one study did not measure QOL at all, one study did not evaluate CIPN symptoms as an outcome; cancer diagnoses/stage and type or number of chemotherapy regimens not specified; no effect sizes reported; only one study using intent to treat analysis; no data extraction or study reporting of adverse events of exercise interventions; selection bias in three of five studies

Nursing Implications

Exercise is a promising strategy in the management of CIPN; however, it is an understudied intervention. Large multi-center RCTs are needed to investigate specific types, doses and duration of exercise interventions tailored to specific cancer populations for CIPN, and related QOL outcome measures to identify best practices that can improve CIPN and related QOL needs.

Print

Kolb, N.A., Smith, A.G., Singleton, J.R., Beck, S.L., Howard, D., Dittus, K., . . . Mooney, K. (2018). Chemotherapy-related neuropathic symptom management: A randomized trial of an automated symptom-monitoring system paired with nurse practitioner follow-up. Supportive Care in Cancer, 26, 1607–1615.

Study Purpose

To evaluate a nursing care model (automated symptom-monitoring and coaching system including NP follow-up of moderate to severe symptoms) to reduce CIPN symptoms.

Intervention Characteristics/Basic Study Process

Patients on taxane/platin therapies called an automated telephone symptom-monitoring system (SCH) daily to report symptoms of numbness and tingling. The system recorded severity, distress, and activity interference on a 0-10 scale. Patients in the telephone-monitoring group received automated self-care strategies and an NP-provided guideline-based care for symptoms rated as 4 or greater. Patients in the usual care group were instructed to call their oncologist for symptom management.

Sample Characteristics

  • N = 252 (238 completed the study)
  • AGE: Mean age = 55.1 years (SD = 11.3)
  • MALES: 51  (21.4%)
  • FEMALES: 187 (78.6%)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Treatment plan of a minimum three cycles of chemotherapy–any disease
  • OTHER KEY SAMPLE CHARACTERISTICS: Must be receiving taxane- or platin-based chemotherapy

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Utah and Vermont

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Secondary sub-analysis of a randomized controlled trial

Measurement Instruments/Methods

Symptom severity measured daily on a 1-10 scale with 10 being most severe. SF-36 and a detailed chemotherapy treatment data sheet were updated monthly. Secondary outcomes were distress associated with numbness and tingling, interference with activities of daily living, and helpfulness of self-care strategies–all scored on a 1-10 scale. Associated symptoms and use of other services were also measured.

Results

The SCH group experienced significantly less symptoms of numbness and tingling and the number of days with neuropathic symptoms of any severity was lower in the SCH group (10.3 versus 17.8, p = 0.02). In addition, the SCH group had less moderate symptom days and less severe days (p < 0.001 and p = 0.006, respectively). Similar trend was seen in distress related to numbness and tingling. NPs called 3.2% of days in the SCH group. For the usual care group, despite 11% of days reporting symptoms 4 or greater, no participants called their HCP for symptom management.

Conclusions

This proactive symptom monitoring intervention was effective in monitoring and intervening for symptoms related to CIPN. Automated self-care strategies for all intervention patients and guideline-based intervention by an NP led to less moderate and severe symptom days in the intervention group. Despite reporting 11% of days with moderate or severe symptoms, no patients in the usual care group called their healthcare provider for symptom management.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Other limitations/explanation: Due to the large number of women with breast cancer, the study was predominately female which limits generalizability to men. Specific strategies patients used to manage symptoms were not collected.

Nursing Implications

Routine monitoring of symptoms using PROs can be completed in a variety of ways and is an actionable tool to improve patient outcomes. This study highlights that patients do not frequently call their HCP when experiencing symptoms and that a proactive approach using a phone-based automated symptom assessment intervention holds promise in symptom management.

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de Andrade, D.C., Jacobsen Teixeira, M., Galhardoni, R., Ferreira, K.S.L., Braz Mileno, P., Scisci, N., . . . de Souza, A.M. (2017). Pregabalin for the prevention of oxaliplatin-induced painful neuropathy: A randomized, double-blind trial. Oncologist, 22, 1154–1155, e99–e105.

Study Purpose

Evaluate the effect on pregabalin given three days prior and three days after each oxaliplatin dose on oxaliplatin-induced peripheral neuropathy

Intervention Characteristics/Basic Study Process

Pregabalin versus placebo given three days prior to and three days after oxaliplatin infusion on weeks 1, 3, and 5 of an 8-week cycle.

Sample Characteristics

  • N = 199 enrolled, 143 in the final analysis (56 participants did not receive at least one full cycle of FOLFOX 
  • AGE: Median = 57 years (mean = 57.13, SD = 10.51)
  • MALES: 99 patients (49.7%)  
  • FEMALES: 100 (50.3%)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: CRC, newly diagnosed stage III/IV
  • OTHER KEY SAMPLE CHARACTERISTICS: Dose of pregabalin was 150-600 mg daily; placebo was also 150-600 mg daily with drug 1 and 150 mg  dose for drug 2.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Multiple sites; Sao Paulo, Brazil

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Randomized, placebo controlled trial

Measurement Instruments/Methods

Main outcome was pain level based on the visual analog scale (rating 0-10) and the brief pain inventory (BPI). Secondary endpoints  were the presence of pain from neuropathy as well the severity of pain based on the Douleur Neuropathique–4 (DN-4), the short-form McGill Pain Questionnaire (MPQ), the Neuropathic Pain Symptom Inventory (NPSI), and any changes in the nerve conduction studies as well as subjective side effect profile.

Results

The pain intensity level of the pregabalin group was 1.03 (95% CI [0.76, 1.26]) and was 0.85 in the placebo group (95% CI [0.64, 1.06]). Quality-of-life scores did not differ between the two groups (placebo QOL was 76.9 [SD = 23.1] and the pregabalin QOL was 79.4 [SD = 20.6]). There were no significant differences in any of the outcome measures.

Conclusions

The intervention was safe, but did not decrease the pain severity or incidence of oxaliplatin-induced peripheral neuropathy.

Limitations

  • Findings not generalizable
  • Other limitations/explanation: Only relevant to oxaliplatin

Nursing Implications

Pregabalin may be safe to take, but does not prevent neuropathy in those receiving oxaliplatin.

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Prinsloo, S., Novy, D., Driver, L., Lyle, R., Ramondetta, L., Eng, C., . . . Cohen, L. (2018). The long-term impact of neurofeedback on symptom burden and interference in patients with chronic chemotherapy-induced neuropathy: Analysis of a randomized controlled trial. Journal of Pain and Symptom Management, 55, 1276–1285.

Study Purpose

To explore the long-term effects of electroencephalographic neurofeedback (NFB) to treat CIPN and other symptoms in cancer survivors.

Intervention Characteristics/Basic Study Process

NFB was given in 20 sessions over a maximum of 10 weeks with rewards for voluntary changes in electroencephalography. For the NFB, sensors were placed on participants scalp in areas deemed important via the EEG assessment. During the sessions, the participants were seated in a comfortable chair and instructed to watch a computer monitor. Feedback occurred when patricians were able to keep the amplitude of a desired EEG waveform above a certain threshold, while inhibiting amplitude of other less-desired waveforms, resulting in emotionally neutral pictures. When thresholds did not match, the game paused, and no feedback was given. Over time, the brain learns to modify its activity under the sensors without input from the NFB system.

Sample Characteristics

  • N = 71 (62 with final data for analysis)
  • AGE: Mean age = 62.5 years (SD = 10.3)
  • MALES: 13%  
  • FEMALES: 87%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Any cancer type was eligible
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants had at least grade 3 neuropathy rating based on the NCI grading criteria or had severe pain without grade 3 neuropathy but had symptoms of neuropathy for a minimum of three months after chemotherapy completion. All post treatment.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Houston, TX

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Study Design

Randomized controlled trial

Measurement Instruments/Methods

Symptom measurements were assessed at baseline, end of treatment, and 1 and 4 months later. They included the BPI-SF, pain quality assessment scale, MDASI, MOS-SF, BFI, Pittsburgh Sleep Quality Index. Each patient had an EEG at baseline and end of treatment.

Results

The NFB group had greater improvement in worst pain and symptoms such as numbness, cancer-related symptom severity, symptom interference, physical functioning, general health and fatigue compared to patients in the wait list control group. There was a significant difference in pain at end of treatment (p < 0.05) and 1 month (p < 0.05) for the NFB group, no significance at 4 months. NFG group reported significant improvement in physical component subscale (p = 0.035); physical functioning (p = 0.037); and general health (p = 0.04) by the end of treatment, no difference at 1 or 4 months. There was also a significant group difference in fatigue at the end of treatment (p = 0.005). There was no effect of NFB on sleep at any timepoint. Large and moderate effect sizes were seen in neuropathic symptoms and QOL measures.

Conclusions

NFB has the potential to have lasting effects on CIPN symptoms as well as symptom burden, QOL, fatigue, and symptom interference.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Intervention expensive, impractical, or training needs
  • Missing data in both groups

Nursing Implications

NFB can significantly reduce symptoms without the adverse effects that medications may have. These results are promising and warrant further research.

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