Trial reportWorld journal of surgical oncology2026
Limb cold therapy for preventing paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study.
Trial report in World journal of surgical oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundPaclitaxel, a widely used chemotherapeutic drug for breast cancer, often causes peripheral neuropathy, which impacts patient quality of life and limits treatment dosages. Cold therapy, involving controlled cold application to extremities, has emerged as a potential non-pharmacological intervention to reduce such neurotoxic effects. This study evaluates the effectiveness of limb cold therapy in preventing and reducing severity paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.
methodsA prospective, randomized controlled study was conducted at the Fourth Hospital of Hebei Medical University from October 2022 to August 2024, involving 200 breast cancer patients undergoing paclitaxel and platinum chemotherapy. Participants were randomized into two groups: the control group receiving standard treatment (n = 103), and the cold therapy group receiving limb cold therapy with ice gloves and socks (n = 97). Outcomes were evaluated across multiple chemotherapy cycles using the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) scales. Neurophysiological assessments and Activities of Daily Living (ADL) tests were conducted to further evaluate the effects. The primary outcome was the incidence and severity of CIPN, assessed using NCI-CTCAE and CIPNAT. Secondary outcomes included FACT/GOG-Ntx, ADL, and neurophysiological parameters.
resultsThe cold therapy group showed a significant reduction in chemotherapy-induced peripheral neuropathy (CIPN) severity from the fourth chemotherapy cycle onwards (e.g., fourth cycle CIPN grade 0: 64.95% vs. 44.66% in control, P = 0.013). CIPNAT scores indicated less severe neuropathy symptoms at the fourth cycle (cold therapy: 124.63 ± 59.21 vs. control: 147.79 ± 77.94, P = 0.019) and sixth cycle (cold therapy: 151.93 ± 61.87 vs. control: 169.64 ± 63.82, P = 0.048). FACT/GOG-Ntx scores showed reduced neurotoxicity in the cold therapy group at the fourth cycle (15.48 ± 3.61 vs. 17.12 ± 3.57, P = 0.001) and at multiple follow-ups. ADL scores improved significantly three months post-chemotherapy (cold therapy: 76.96 ± 5.11 vs. control: 74.61 ± 5.21, P = 0.002). Neurophysiological assessments revealed better nerve conduction parameters in the cold therapy group, including decreased distal motor latency (DML) and improved compound muscle action potential amplitude.
conclusionLimb cold therapy may help mitigate PIPN symptoms, improve quality of life scores, and preserve peripheral nerve function in breast cancer patients.
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