Limb cold therapy significantly reduced the incidence of any-grade paclitaxel-induced peripheral neuropathy at the sixth chemotherapy cycle compared to standard care (69.07% vs. 86.41%, p=0.003).
RCT (n=200)
Assessor-blinded
Permuted block randomization with block sizes varying randomly between 2 and 4
No
Does limb cold therapy reduce the incidence and severity of paclitaxel-induced peripheral neuropathy in female breast cancer patients?
Limb cold therapy significantly reduces the incidence and severity of paclitaxel-induced peripheral neuropathy and improves quality of life in breast cancer patients.
Absolute Event Rate: 69.07% vs 86.41%
p-value: p=0.003
Paclitaxel, 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. A 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. The 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. Limb cold therapy may help mitigate PIPN symptoms, improve quality of life scores, and preserve peripheral nerve function in breast cancer patients.
Wu et al. (Mon,) conducted a rct in Breast cancer (n=200). Limb cold therapy (ice gloves and socks) vs. Room-temperature gloves and socks was evaluated on Incidence of any-grade chemotherapy-induced peripheral neuropathy (CTCAE ≥1) at the sixth chemotherapy cycle (p=0.003). Limb cold therapy significantly reduced the incidence of any-grade paclitaxel-induced peripheral neuropathy at the sixth chemotherapy cycle compared to standard care (69.07% vs. 86.41%, p=0.003).