Clinical trialBreast cancer

Effects of exercise during chemotherapy on chemotherapy-induced peripheral neuropathy: a multicenter, randomized controlled trial

Support Care Cancer · 2017355 patients
Kleckner IR, Kamen C, Gewandter JS, Mohile NA, Heckler CE, Culakova E, et al. Support Care Cancer. 2017. 26:1019-1028
Study type
Clinical trial
Study name
EXCAP
Design
Secondary analysis of a nationwide multicentre phase 3 randomised controlled trial (parent trial: exercise for fatigue)
Sample size
355 patients
Source
Support Care Cancer · 2017
Trial registration
NCT00924651

In plain words

Nerve damage caused by chemotherapy (peripheral neuropathy) causes numbness, tingling and feelings of heat or cold in the hands and feet, and there is no approved medicine for it. In this study, patients who did a six-week home exercise programme (walking and resistance exercises) alongside chemotherapy had fewer symptoms of this side effect. The benefit seemed to be greater in older patients, men and people with breast cancer. Before starting any exercise programme, talk with your treating doctor.

Key results

0.46-unit reduction in the exercise group versus control
Hot/cold symptoms in the hands/feet
p = 0.045
0.42-unit reduction in the exercise group versus control
Numbness and tingling
p = 0.061
Greater symptom reduction with exercise
Moderator: older age
p = 0.086
Greater symptom reduction with exercise
Moderator: male sex
p = 0.028
Greater symptom reduction with exercise
Moderator: breast cancer
p = 0.076

Treatment arms and regimens

1Control group

Neurotoxic chemotherapy (taxane-‎, platinum-‎ or vinca alkaloid-based) per standard care, without an exercise programme; assessments and follow-up were exactly as in the intervention group, and the exercise programme was offered to these patients after all assessments were complete.

2Intervention group

No drug (exercise intervention). Chemotherapy plus the "Exercise for Cancer Patients" (EXCAP) programme: a kit with a manual, a pedometer and three resistance bands, with instruction in one 60-minute session on the first day of chemotherapy.

  • Walking: daily at low to moderate intensity (60 to 85% of heart rate reserve) for 6 weeks; individual prescription based on mean baseline daily steps (4-day pedometer recording before randomisation), increasing step counts by 5 to 20 percent each week.
  • Resistance-band training: daily at low to moderate intensity (RPE 3 to 5) for 6 weeks; ten exercises (squat, side bend, knee extension, knee flexion, chest press, row, heel raise, overhead press, biceps curl and triceps extension) and four optional exercises, with weekly increases in sets and repetitions (up to 4 sets of 15 repetitions) and band resistance.

Source of the regimen details: No drug (exercise intervention); exercise prescription and inclusion criteria from the full text (PMC5823751, Study participants and Exercise intervention sections)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Patients with cancer (355; age 56 ± 11 years; 93% women; 79% with breast cancer) receiving taxane-‎, platinum-‎ or vinca alkaloid-based chemotherapy. Parent trial criteria: age 21 years or older, a primary cancer other than leukaemia without distant metastasis, no prior chemotherapy, starting chemotherapy after enrolment with at least 6 weeks of treatment in ‎2-‎, ‎3-‎ or 4-week cycles, Karnofsky score of at least 70, no concurrent radiotherapy, no physical limitation for a home walking and resistance-training programme as judged by the oncologist, and not in the action or maintenance stage of exercise behaviour.

Endpoints

Symptoms of chemotherapy-induced peripheral neuropathy (CIPN), including numbness and tingling and hot/cold sensations in the hands/feet, patient-reported on 0 to 10 scales before and after the intervention. Predictors of CIPN symptoms and moderators of the exercise effect (baseline neuropathy, sex, age, body mass index, cancer stage and cancer type) were also examined.

Safety and side effects

During the study, 5 participants had grade 3 to 5 adverse events (3 non-serious and 2 serious), including lymphopenia, neutropenia and multi-organ failure; all were unrelated to the exercise intervention.

Clinical significance and place in guidelines

Based on this secondary analysis, exercise may reduce neuropathy symptoms caused by taxanes, platinum or vinca alkaloids, and the authors recommend that clinicians consider prescribing exercise for these patients. The status of this recommendation in authoritative clinical guidelines should be checked separately; the abstract gives no information on this.

Limitations

This was a secondary analysis of a trial designed to study the effect of exercise on fatigue. CIPN symptoms were self-reported on 0 to 10 scales. The effect on numbness and tingling was not statistically significant (p = 0.061). The moderating effects of age and breast cancer also did not reach significance, and the effect of male sex was examined in a sample that was 93% women. These findings are exploratory and need confirmation in further studies.

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.