Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy

This is a prospective, multicenter, open-label randomized controlled trial to evaluate oral mecobalamin for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients with solid tumors receiving taxane-based chemotherapy. Participants are assigned to receive prophylactic mecobalamin (0.5 mg orally three times daily, starting on the first day of taxane-based chemotherapy and continuing until chemotherapy completion) or no routine mecobalamin prophylaxis. The primary endpoint is the cumulative incidence of grade ≥2 CIPN (CTCAE v6.0) from randomization to the end of chemotherapy. Secondary endpoints include measures of CIPN onset and severity, patient-reported outcomes (PROs), chemotherapy delivery, and safety. Study assessments are conducted at baseline and during each chemotherapy cycle.