Preventing taxane-related peripheral neuropathy with oral mecobalamin

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

This trial will test whether taking oral mecobalamin during taxane chemotherapy can prevent or reduce numbness, tingling, and pain in the hands and feet of adults with solid tumors.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 326 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qinghai Red Cross Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Xining, Qinghai and 3 other locations)
• Trial ID: NCT07423390 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, open-label randomized trial comparing prophylactic oral mecobalamin to no routine mecobalamin prophylaxis in adults receiving taxane-based chemotherapy for solid tumors. Participants randomized to mecobalamin take 0.5 mg orally three times daily from the first day of taxane treatment until chemotherapy completion. The primary endpoint is the cumulative incidence of grade ≥2 chemotherapy-induced peripheral neuropathy (CTCAE v6.0) from randomization to the end of chemotherapy, with secondary endpoints including onset and severity measures, patient-reported outcomes, chemotherapy delivery, and safety. Assessments occur at baseline and during each chemotherapy cycle at participating centers in China.

Who should consider this trial

Good fit: Adults (≥18) with confirmed solid tumors who are starting adjuvant, neoadjuvant, or first-line taxane-based chemotherapy, have ECOG 0–2, adequate organ function, life expectancy ≥3 months, and no pre-existing peripheral neuropathy are ideal candidates.

Not a fit: Patients with pre-existing peripheral neuropathy, prior neurotoxic chemotherapy, non-taxane regimens, severe organ impairment, or inability to take oral supplements are unlikely to benefit from this prevention approach.

Why it matters

Potential benefit: If successful, patients may have lower rates of moderate-to-severe taxane-induced neuropathy, helping preserve quality of life and enabling planned chemotherapy dosing.

How similar studies have performed: Methylcobalamin has shown promise in small trials for other neuropathies, but robust phase III evidence specifically preventing taxane-induced CIPN is limited.

Eligibility criteria

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.

Where this trial is running

Xining, Qinghai and 3 other locations

• Affiliated Hospital of Qinghai University — Xining, Qinghai, China (NOT_YET_RECRUITING)
• Qinghai Red Cross Hospital — Xining, Qinghai, China (RECRUITING)
• Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital) — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Beijing Chaoyang Sanhuan Cancer Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Jiuda Zhao, Dr

Conditions: Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Chemotherapy-induced, Chemotherapy induced peripheral neuropathy, Mecobalamin, Taxane, Prevention