TENS, Compression, and Cryotherapy for Paclitaxel-Induced Peripheral Neuropathy in Women With Breast Cancer

This single-center, four-arm, parallel-group randomized controlled trial evaluates transcutaneous electrical nerve stimulation (TENS), compression, and cryotherapy for the management of chemotherapy-induced peripheral neuropathy (CIPN) in women with breast cancer receiving weekly adjuvant paclitaxel. A total of 140 participants with NCI-CTCAE Version 5.0 Grade 2 peripheral sensory neuropathy before the third weekly paclitaxel infusion were randomized in a 1:1:1:1 ratio to TENS, compression, cryotherapy, or routine care. The interventions were administered during weekly paclitaxel sessions from weeks 3 through 12. Outcomes were assessed at baseline before the third weekly infusion and before the sixth, ninth, and twelfth weekly infusions. The primary outcome is the EORTC QLQ-CIPN20 total score during the treatment period.

Inclusion Criteria: * Female and 18 years of age or older. * Diagnosed with early-stage or locally advanced breast cancer. * Receiving 12 weeks of weekly paclitaxel as adjuvant treatment. * Clinically confirmed National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0 Grade 2 peripheral sensory neuropathy during the third week of paclitaxel treatment, before the third weekly infusion and randomization. * Eastern Cooperative Oncology Group performance status of 0-2 and Karnofsky Performance Status greater than 70. * Able to communicate and complete the study procedures. * Provided written informed consent to participate. Exclusion Criteria: * Peripheral neuropathy present before initiation of paclitaxel treatment. * Diabetic neuropathy or another neurological disorder that could affect the assessment of peripheral neuropathy. * Receiving paclitaxel as neoadjuvant, metastatic, or palliative treatment. * Cardiac pacemaker or another implanted electronic device contraindicating transcutaneous electrical nerve stimulation. * Active infection, open wound, serious skin lesion, or clinically significant peripheral circulatory impairment in the upper or lower extremities where the interventions would be applied. * Raynaud phenomenon, cryoglobulinemia, cold urticaria, or another clinical condition contraindicating cryotherapy. * Regularly receiving another physical intervention for chemotherapy-induced peripheral neuropathy outside the study at enrollment or planning to receive such an intervention during the study.