The effects of frozen gloves and socks on paclitaxel-induced peripheral neuropathy among patients with breast cancer: A self-controlled clinical trial.

10022 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and disabling side effect with no proven effective treatment or prevention. In this prospective study, we aimed to evaluate the effectiveness of frozen gloves and socks (FGS) in preventing CIPN. Methods: The study included breast cancer patients who were treated weekly with paclitaxel (80 mg/m2 for 1 h) for at least 12 cycles. Each patient wore FGS on the dominant hand (H) and foot (F) for 90 min during infusion. The non-dominant side acted as the untreated control. The primary endpoint was an incidence of CIPN (any grade) assessed by the Semmes–Weinstein monofilament test (MF; tactile changes from baseline) at 12 weeks. We also assessed FGS tolerability, thermal threshold using a thermal stimulator (TS), subjective symptoms using the Patient Neurotoxicity Questionnaire (PNQ), and manipulative dexterity using the grooved pegboard (GP) test. The McNemar’s test (MF, TS, and PNQ) and paired t-test (GP) were used for statistical analysis. Results: Of 44 patients registered, four did not undergo any intervention (two did not meet inclusion criteria and two withdrew). An additional four did not complete 12 cycles of paclitaxel due to pneumonia (n = 1), severe fatigue (n = 1), hepatopathy (n = 1), and macular edema (n = 1), leaving 36 patients for the analysis. No patient dropped out because of cold intolerance. The incidence of CIPN assessed by MF (primary endpoint), TS (hot), and moderate to severe tingling, pain, or numbness, which interfered with daily living (PNQ), were significantly lower in the intervention side than in the control side (Table). The GP test showed that the deterioration of manipulative dexterity was also significantly prevented (mean delay, −2.5 vs 8.6 sec; p <0.01). Conclusions: FGS is useful in mitigating the objective and subjective symptoms of CIPN and its resultant dysfunction. Clinical trial information: UMIN000013398.n (%) Intervention (n = 36) Control (n = 36) p Objective CIPN (MF) H 10 (28%) 29 (81%) <0.01 F 9 (25%) 23 (64%) <0.01 (TS Hot) H 3 (8%) 12 (33%) 0.01 F 12 (33%) 20 (56%) 0.04 (TS Cold) H 1 (3%) 5 (14%) 0.13 F 4 (11%) 7 (19%) 0.45 Subjective CIPN (PNQ) H 3 (8%) 21 (58%) <0.01 F 7 (19%) 24 (67%) <0.01