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

Qinghai Red Cross Hospital

Status and phase: Enrolling; Phase 3

Conditions: Peripheral Neuropathy, Chemotherapy-induced; Peripheral Neuropathy Due to Chemotherapy

Treatments: Drug: Mecobalamin

Study type: Interventional

Funder types: Other

Identifiers

NCT07423390

KY-2025-214

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 326 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Age ≥18 years;
3. 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;
4. Life expectancy ≥3 months;
5. ECOG performance status 0-2;
6. Adequate major organ function (cardiac, hepatic, renal, and bone marrow function);
7. Willing and able to provide written informed consent and comply with study procedures.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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326 participants in 2 patient groups

Mecobalamin Prophylaxis

Experimental group

Description:

Participants receive oral mecobalamin 0.5 mg three times daily (total 1.5 mg/day), starting on the first day of taxane chemotherapy and continuing until completion of chemotherapy. If CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.

Treatment:

Drug: Mecobalamin

No Routine Mecobalamin Prophylaxis

No Intervention group

Description:

Participants do not receive routine mecobalamin prophylaxis. Follow-up schedule, education, and outcome assessments are the same as in the mecobalamin group. If CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.