Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy (NCT07423390) | Clinical Trial Compass
RecruitingPhase 3
Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
China326 participantsStarted 2026-02-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN)
Timeframe: From randomization up to 24 weeks (maximum planned chemotherapy duration).