Feet Cooling As a Preventive Strategy against Chemotherapy-Induced Peripheral Neuropathy in Advanced Breast Cancer Patients: A Randomized Clinical Trial
Abstract
BACKGROUND
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating adverse effect of taxane-based chemotherapy, often persisting long after treatment completion. This study evaluates the efficacy of continuous foot cooling with an adjustable temperature wrap during taxane infusion to prevent CIPN in breast cancer patients.
METHODS
In this open-label randomized controlled trial, 120 patients with stage I to III breast cancer undergoing paclitaxel-based chemotherapy were randomly assigned to an intervention group receiving continuous feet cooling (13°C-16°C) initiated 30 minutes before and maintained until 15 minutes after chemotherapy infusion, alongside standard care, or to a control group receiving standard care alone. CIPN was assessed using the modified EORTC QLQ-CIPN20 questionnaire at 6 weeks (t1), 12 weeks (t2), and 3 months post-treatment (t3).
RESULTS
Baseline characteristics were balanced between groups. The intervention group demonstrated significantly lower-limb CIPN scores compared to controls at all time points: week 6 (21.58 ± 5.89 vs. 26.28 ± 7.78; P < .001), week 12 (22.75 ± 7.15 vs. 28.56 ± 6.99; P < .001), and 3 months post-treatment (19.73 ± 5.90 vs. 26.65 ± 19.48; P < .001). The number needed to treat (NNT) was 7, indicating a moderate protective effect. Foot cooling was well tolerated, with no differences in chemotherapy dose modifications.
CONCLUSION
Continuous foot cooling during chemotherapy significantly reduces the incidence…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 120 participants or records.
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