Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQinghai Red Cross Hospital
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Mecobalamin
Treatment groups
326 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov