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Clinical trial Recruiting at 2 sites Phase 3 Interventional Ages 18 and up

Preventing taxane-related peripheral neuropathy with oral mecobalamin

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

Run by Qinghai Red Cross Hospital · NCT07423390 · Data updated 2026-11-12

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

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment326 (estimated)
SponsorQinghai Red Cross Hospital
Academic / other
Drugs / interventionschemotherapy
Locations4 sites (Xining, Qinghai and 3 other locations)
StatusRecruiting
StartedFebruary 24, 2026
Main results expectedMarch 30, 2029
Study endsMay 31, 2029
Registry record updatedApril 30, 2026
Trial IDNCT07423390 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Qinghai Red Cross Hospital
    Xining, Qinghai, China     Recruiting
  • Beijing Chaoyang Sanhuan Cancer Hospital
    Beijing, China     Recruiting
  • Affiliated Hospital of Qinghai University
    Xining, Qinghai, China     Not yet recruiting
  • Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
    Jinan, Shandong, China     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Peripheral Neuropathy Due to Chemotherapy 6Qinghai Red Cross Hospital 5
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.