Abstract
BACKGROUND: Paclitaxel-induced peripheral neuropathy (PIPN) is a dose-limiting adverse effect during paclitaxel therapy, with no effective treatment and often incomplete recovery. This study assessed the effects of exercise on PIPN severity in newly diagnosed advanced breast cancer patients. METHODS: The ExPIN Trial is an ongoing randomized clinical trial. This interim analysis, conducted between November 2022 and December 2023, included adult patients with locally advanced, non-metastatic breast cancer. Participants were randomized into interventional and control groups for 0 to 12 weeks. The primary outcome was nerve conduction studies. Secondary outcomes included balance scores, taxane-induced toxicity-related quality-of-life scores, emotional functioning, physical functioning, and functional impairments assessed at baseline, after chemotherapy, and at the first follow-up. RESULTS: Seventy patients were randomized. The mean (SD) age was 49.46 (9.52) years in the interventional group and 49.09 (8.10) years in the control group. At the completion of paclitaxel therapy, the amplitudes of the ulnar nerve (estimate: 1.98, P = .007), common peroneal nerve (estimate: 1.88, P = .003), and sural nerve (estimate: 6.20, P < .001) were significantly higher in the interventional group. On the EORTC scale (lower scores indicate better quality of life), sensory and motor scores significantly decreased in the interventional group by the end of therapy (-5.46 and -3.82, P < .001), indicating improvement. These improvements were sustained at follow-up (-1.99, P = .001, and -4.20, P < .001, respectively). CONCLUSIONS: Exercise intervention during paclitaxel therapy significantly reduced PIPN severity and improved quality of life. Findings are preliminary and warrant further confirmation.