Vitamin B12 shows promise in preventing chemo side effect
NCT ID NCT05165069
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether mecobalamin (a form of vitamin B12) can prevent severe hand-foot syndrome in early breast cancer patients taking capecitabine. About 234 women will receive either mecobalamin or a placebo. The goal is to see if the vitamin reduces painful skin reactions on hands and feet, helping patients stay on treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 234 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female, aged 18 to 75 2. Her-2 negative patients with non metastatic breast cancer. 3. patients with early breast cancer who did not receive PCR after neoadjuvant chemotherapy or patients with lymph node metastasis after breast cancer surgery. 4. Prepare to receive postoperative adjuvant single drug capecitabine or capecitabine combined with endocrine therapy and / or radiotherapy The Binbin dose is 1000mg / ㎡, bid (continuous oral administration for 14 days, stopping for 7 days, repeated every 21 days) 5. Eastern cancer cooperation group (ECoG) physical strength score 0-1; 6. During randomization, the toxicity related to previous treatment must be alleviated to NCI CTCAE (version 4.03) ≤ 1 degree (except hair loss or according to the research) Other toxicity judged by the investigator that there is no risk to the safety of the patient); 7. Blood routine examination was basically normal within 4 weeks before enrollment: A. white blood cell count (WBC) ≥ 3.0 × 10 \^ 9 / L, B. medium Sex granulocyte count (ANC) ≥ 1.5 × 10 \^ 9 / L, C. platelet count (PLT) ≥ 100 × 10\^9/L; 8. The liver and kidney function tests were basically normal within 4 weeks before enrollment (based on the normal values in the laboratories of each research center): a Total bilirubin (TBIL) ≤ 1.5 × Upper limit of normal value (ULN), B. alanine aminotransferase and aspartate aminotransferase (ALT / AST) ≤2.5 × ULN (patients with liver metastasis) ≤ 5 × ULN), C. serum creatinine ≤ 1.5 × ULN or creatinine clearance (CCR) ≥60 ml/min; 9. Women of childbearing age must have a serum / urine pregnancy test 4 weeks before enrollment, and the result is negative, and are willing to participate in the study Use a medically recognized high-efficiency contraceptive during and within 6 months after the last administration of the drug; 10. Informed consent has been signed before joining the group; 11. There was no active infectious disease within 12 weeks of screening period Exclusion Criteria: 1. in the first 5 years of randomised allocation, there was a history of malignancy except for breast cancer, but the risk of metastasis or death was negligible. Except for malignant tumors that can be cured after treatment (such as appropriately treated cervical carcinoma in situ, non melanoma skin cancer or stage I cancer) Uterine cancer, thyroid cancer, etc.); 2. Any accompanying disease or condition that may interfere with the study, or any serious medical impairment that may affect the safety of the subject (for example, uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection); 3. there are diseases affecting skin: diabetes, dermatomyositis, sclerosing disease, lupus erythematosus and so on. 4. Known history of psychotropic substance abuse or drug abuse; 5. Pregnant or lactating patients; 6. Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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