Peripheral Neuropathy Due to ChemotherapyPeripheral Neuropathy, Chemotherapy-induced
Investigational drug(s) / intervention(s)
Mecobalamin
Mecobalamin: Oral mecobalamin tablets, 0.5 mg three times daily (total 1.5 mg/day), starting on Day 1 of taxane-based chemotherapy and continuing until completion of chemotherapy, administered as prophylaxis for chemotherapy-induced peripheral neuropathy. Participants in both groups are not permitted to use any other medications or supplements specifically for the prophylaxis of CIPN during the study period. However, if CIPN-related symptoms (e.g., pain, paresthesia) occur, the treating physician will provide standard symptomatic treatment in accordance with current clinical guidelines.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Cumulative incidence of grade ≥2 chemotherapy induced peripheral neuropathy (CIPN) — From randomization up to 24 weeks (maximum planned chemotherapy duration). Defined as the proportion of participants who experience grade ≥2 CIPN (assessed by CTCAE v6.0) at any time from randomization to the end of chemotherapy (or earlier discontinuation).
Trial sites (4)
Facility
City
Region
Status
Affiliated Hospital of Qinghai University
Xining
Qinghai
Not Yet Recruiting
Qinghai Red Cross Hospital
Xining
Qinghai
Recruiting
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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