The effect of cold therapy on vincristine-induced peripheral neuropathy in pediatric oncology patients: A pilot randomized controlled trial.

PURPOSE: This pilot randomized controlled trial (RCT) aim to evaluate the feasibility of a nurse-led cold therapy intervention in children receiving vincristine while exploring its potential effects on Vincristine-induced peripheral neuropathy (VIPN) severity, pain, and quality of life (QoL). METHODS: This single-center, statistician-blinded pilot RCT followed CONSORT guidance and Symptom Management Theory. Thirty-six children aged 7-18 years receiving vincristine were randomized to cold therapy (n = 18) or standard care (n = 18). Cold gloves and socks were applied for 15 min during each vincristine administration. Primary outcomes were tolerability, acceptability, adherence, and safety. Neuropathy severity and pain were assessed as exploratory clinical outcomes weekly for 12 weeks, while QoL was assessed monthly. RESULTS: Feasibility outcomes showed that the target sample size was achieved (n = 36), with 94.7% of eligible participants randomized (36/38), 100% retention (36/36), and complete data capture with no missing data. Cold therapy was well tolerated, with full adherence to the intervention and no adverse events occurred. Acceptability was high among children (7.57 ± 3.31) and parents (8.43 ± 2.18). Significant group effects favored the intervention for pain, paresthesia, motor neuropathy, and QoL (all p < 0.01), but not sensory neuropathy (p = 0.090). QoL showed a time effect (p = 0.046), with no group-by-time interactions. CONCLUSIONS: Cold therapy was feasible, well-tolerated, and associated with lower neuropathy and pain scores and higher QoL in children receiving vincristine, supporting its potential as a nurse-led, non-pharmacological symptom management strategy.