RecruitingPhase 3NCT07423390

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

Sponsor

Qinghai Red Cross Hospital

Enrollment

326 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

Peripheral Neuropathy Due to Chemotherapy Peripheral Neuropathy, Chemotherapy-induced

Summary

Some patients receiving taxane-based chemotherapy experience numbness, tingling, or pain in their hands and feet, known as chemotherapy-induced peripheral neuropathy (CIPN). This study aims to find out whether oral mecobalamin can prevent or reduce CIPN. Participants will be assigned to take mecobalamin or to receive no routine mecobalamin prevention during chemotherapy, and outcomes will be compared between groups.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Histologically or cytologically confirmed solid tumors, including but not limited to breast cancer, lung cancer, gastric cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and melanoma;
Age ≥18 years;
Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (including paclitaxel, nab-paclitaxel, or docetaxel; as monotherapy or in combination) for early-stage disease, or has advanced disease with no prior chemotherapy;
Life expectancy ≥3 months;
ECOG performance status 0-2;
Adequate major organ function (cardiac, hepatic, renal, and bone marrow function);
Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria7

Severe impairment of major organ function such that the participant cannot tolerate standard-dose chemotherapy;
Pre-existing peripheral neuropathy or a history of peripheral neuropathy;
Skin conditions (e.g., severe palmoplantar keratoderma, active skin infection) that may interfere with assessment of CIPN symptoms;
Recent use of medications that may alleviate CIPN symptoms;
Inability to swallow, intestinal obstruction, or other conditions that may affect drug absorption;
Known hypersensitivity or allergy to mecobalamin;
Pregnant or breastfeeding women.

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Interventions

DRUGMecobalamin

Oral mecobalamin tablets, 0.5 mg three times daily (total 1.5 mg/day), starting on Day 1 of taxane-based chemotherapy and continuing until completion of chemotherapy, administered as prophylaxis for chemotherapy-induced peripheral neuropathy. Participants in both groups are not permitted to use any other medications or supplements specifically for the prophylaxis of CIPN during the study period. However, if CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.