Peripheral Neuropathy Clinical Trials

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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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 to 80 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.

Locations
Other Locations
China
Beijing Chaoyang Sanhuan Cancer Hospital
RECRUITING
Beijing
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
NOT_YET_RECRUITING
Jinan
Affiliated Hospital of Qinghai University
NOT_YET_RECRUITING
Xining
Qinghai Red Cross Hospital
RECRUITING
Xining
Contact Information
Primary
Jiuda Zhao, Dr
jiudazhao@126.com
869716230893
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 326
Treatments
Experimental: Mecobalamin Prophylaxis
Participants receive oral mecobalamin 0.5 mg three times daily (total 1.5 mg/day), starting on the first day of taxane chemotherapy and continuing until completion of chemotherapy. If CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.
No_intervention: No Routine Mecobalamin Prophylaxis
Participants do not receive routine mecobalamin prophylaxis. Follow-up schedule, education, and outcome assessments are the same as in the mecobalamin group. If CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.
Related Therapeutic Areas
Sponsors
Leads: Qinghai Red Cross Hospital

This content was sourced from clinicaltrials.gov