Efficacy of surgical glove-compression therapy as a prevention of paclitaxel-induced peripheral neuropathy: Randomized controlled trial.

Abstract

12131 Background: Paclitaxel is a common cause of chemotherapy-induced peripheral neuropathy (CIPN), a dose-limiting toxicity for which no preventive intervention is currently recommended. This randomized controlled trial evaluated the efficacy of surgical glove-compression therapy (SGCT) in preventing paclitaxel-induced peripheral neuropathy. Methods: Patients with solid malignancies scheduled to receive paclitaxel every three weeks were randomized 1:1 to SGCT or placebo. SGCT consisted of bilateral double-layer surgical gloves one size smaller than patient’s hand size, covered with outer cotton gloves, worn from 30 minutes before paclitaxel infusion until 30 minutes after completion. The placebo group wore non-compression gloves with identical cotton gloves for the same duration. Patients were followed for four cycles of paclitaxel. The primary endpoint was the incidence of paclitaxel-induced sensory neuropathy of Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 grade ≥2. Secondary endpoints included Patient Neurotoxicity Questionnaire (PNQ) grade ≥D, Functional Assessment of Cancer Therapy–Gynecologic Oncology Group–Neurotoxicity (FACT/GOG-NTX) scores, and loss of protective sensation assessed by monofilament testing. Analyses were conducted using the intention-to-treat approach. Sensitivity analyses included per-protocol analysis and treatment effect adjustment for important prognostic factors for CIPN. Results: Between November 2024 and November 2025, 39 patients were randomized to SGCT (n=19) or placebo (n=20). Most patients were female, had breast cancer, and received single-agent paclitaxel. In the intention-to-treat analysis, sensory CIPN grade ≥2 occurred significantly less frequently in the SGCT group than in the placebo group (26.3% vs. 60.0%; p=0.034). This finding was consistent in the per-protocol analysis (27.8% vs. 66.7%; p=0.019). The protective effect of SGCT remained statistically significant after adjustment for sex, cancer type, and chemotherapy regimen (adjusted OR 0.10; 95% CI, 0.02 to 0.58; p=0.010). No significant differences were observed in secondary outcomes, including motor CIPN, PNQ grade ≥D, monofilament test abnormalities, or FACT/GOG-NTX scores. Any-grade sensory CIPN was common and did not differ between groups. SGCT was well tolerated, with no serious adverse events and high adherence. Conclusions: SGCT significantly reduced the incidence of clinically meaningful paclitaxel-induced sensory neuropathy and was safe and well-tolerated. These findings support SGCT as a simple, low-cost preventive strategy for CIPN. Clinical trial information: NCT06763575 .