NCT07423390 Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
| NCT ID | NCT07423390 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qinghai Red Cross Hospital |
| Condition | Peripheral Neuropathy Due to Chemotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 326 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 326 participants in total. It began in 2026-02-24 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07423390 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Neuropathy Due to Chemotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07423390 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 326 participants.
Is NCT07423390 currently recruiting?
Yes, NCT07423390 is actively recruiting participants. Contact the research team at jiudazhao@126.com for enrollment information.
Where is the NCT07423390 trial being conducted?
This trial is being conducted at Xining, China, Xining, China, Jinan, China, Beijing, China.
Who is sponsoring the NCT07423390 clinical trial?
NCT07423390 is sponsored by Qinghai Red Cross Hospital. The trial plans to enroll 326 participants.