Actively Recruiting
Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
Led by Qinghai Red Cross Hospital · Updated on 2026-04-30
326
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether oral mecobalamin can prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) in patients with solid tumors receiving taxane-based chemotherapy. This prospective, multicenter, open-label randomized controlled trial focuses on the common side effects of numbness, tingling, or pain in the hands and feet that some patients experience during taxane chemotherapy. The study aims to compare outcomes between those taking mecobalamin and those receiving no routine mecobalamin prevention.
CONDITIONS
Brief Title
Study on the Efficacy and Safety of Mecobalamin in Preventing Taxane-related Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed solid tumors such as breast, lung, gastric, cervical, endometrial, ovarian, pancreatic cancer, or melanoma
- Age 18 years or older
- Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (paclitaxel, nab-paclitaxel, or docetaxel) for early-stage disease or has advanced disease with no prior chemotherapy
- Life expectancy of at least 3 months
- ECOG performance status between 0 and 2
- Adequate major organ function including cardiac, hepatic, renal, and bone marrow
- Willing and able to provide written informed consent and follow study procedures
You will not qualify if you...
- Severe impairment of major organ function preventing standard-dose chemotherapy
- Pre-existing peripheral neuropathy or history of peripheral neuropathy
- Skin conditions such as severe palmoplantar keratoderma or active skin infection that interfere with neuropathy symptom assessment
- Recent use of medications that may relieve neuropathy symptoms
- Inability to swallow, intestinal obstruction, or other conditions affecting drug absorption
- Known allergy or hypersensitivity to mecobalamin
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks (maximum planned chemotherapy duration)
Participants receive taxane-based chemotherapy. Those assigned to the experimental group take oral mecobalamin three times daily starting on the first day of chemotherapy and continuing until chemotherapy completion. Participants are monitored for chemotherapy-induced peripheral neuropathy and other outcomes.
Assessments at baseline and during each chemotherapy cycle
Duration - 6 months after chemotherapy completion
Participants are monitored for safety and patient-reported outcomes after chemotherapy completion, including assessments at 1 week, 1 month, and 6 months post-chemotherapy.
3 follow-up visits (1 week, 1 month, and 6 months after chemotherapy)
Trial Site Locations
Total: 4 locations
1
Affiliated Hospital of Qinghai University
Xining, Qinghai, China
Not Yet Recruiting
2
Qinghai Red Cross Hospital
Xining, Qinghai, China
Actively Recruiting
3
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
Jinan, Shandong, China
Not Yet Recruiting
4
Beijing Chaoyang Sanhuan Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jiuda Zhao, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here