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Active, not recruitingNCT05165069Updated Feb 2, 2026

The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome

A Phase 3 interventional study of Mecobalamin 5 MG Disintegrating Oral Tablet and placebo in Hand-foot Syndrome, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

A multicenter, randomized, placebo-controlled, double-blind, phase III clinical trial will be conducted to explore the efficacy and safety of mecobalamin in the prevention of 2/3 HFS in patients with early breast cancer. 234 patients will be enrolled and will be randomized into mecobalamin group and placebo group at the ration of 1:1. The incidence of grade 2 / 3 HFS in the experimental group and the control group will be observed. This study is expected to provide evidence for clinical prevention of hand foot syndrome, improve clinical treatment guidelines for early breast cancer, and provide reference for other antitumor drugs for hand foot syndrome.

Read the detailed description

Capecitabine is a drug recommended for adjuvant therapy in early breast cancer. The key to improving the prognosis of early breast cancer is to ensure that adequate treatment is sufficient. Hand foot syndrome Hand foot syndrome (HFS) is the most common and specific side effect of capecitabine, in which the incidence of grade 2 / 3 HFS requiring treatment is as high as 17-36%. At present, there is no specific drug for the treatment of HFS, and capecitabine must be reduced or stopped in case of grade 2 / 3 HFS. The guidelines also do not recommend standard drugs for the prevention of HFS. Mecobalamin is a derivative of vitamin B12, which can improve autonomic nervous system After symptoms and repair of small neuropathy, its clinical indication is the treatment of peripheral neuropathy.

A multicenter, randomized, placebo-controlled, double-blind, phase III clinical trial will be conducted to explore the efficacy and safety of mecobalamin in the prevention of 2/3 HFS in patients with early breast cancer. 234 patients will be enrolled and will be randomized into mecobalamin group and placebo group at the ration of 1:1. The incidence of grade 2 / 3 HFS in the experimental group and the control group will be observed. This study is expected to provide evidence for clinical prevention of hand foot syndrome, improve clinical treatment guidelines for early breast cancer, and provide reference for other antitumor drugs for hand foot syndrome.

02

Conditions studied

  • Hand-foot Syndrome

Keywords

  • Hand-foot Syndrome, Mecobalamin, Capecitabine, Breast Cancer
03

In context

Hand-Foot Syndrome

45 studies on the registry are indexed under Hand-Foot Syndrome; 9 are open to participants now.

This study's planned enrollment of 234 is above the median of 60 across 36 interventional studies indexed under Hand-Foot Syndrome.

Browse Hand-Foot Syndrome studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
234 participants (estimated)

Study arms

  • Experimental
    Mecobalamin group

    Mecobalamin (0.5mg / time, 3 times / day) for 6 months

    Drug: Mecobalamin 5 MG Disintegrating Oral Tablet

  • Placebo comparator
    Placebo group

    placebo (0.5mg / time, 3 times / day) for 6 months

    Drug: placebo

Interventions

  • DrugMecobalamin 5 MG Disintegrating Oral Tablet

    Mecobalamin 0.5mg / time, 3 times / day,was taken continuously for 6 months

  • Drugplacebo

    placebo 0.5mg / time, 3 times / day,was taken continuously for 6 months

06

What researchers measure

Primary outcomes

  1. The incidence of grade 2 / 3 hand foot syndrome

    The incidence equals the numbers of patients happens 2nd or 3rd level hand foot syndrome/the number of total patients in each group

    Time frame: 6 months

Secondary outcomes

  1. The reduction or withdrawal rate of capecitabine

    the proportion of subjects with capecitabine reduction of more than 75% or capecitabine withdrawal accounted for the proportion of subjects in each group

    Time frame: 6 months

  2. Disease Free Survival

    The time from the beginning of treatment to the recurrence of the disease or death from any cause or the end of the visit

    Time frame: 5 years

  3. Overall Survival

    The time from the beginning of treatment to the death of the patient caused by any factor

    Time frame: 5 year

  4. The score of life quality questionnaire

    The score of HF-Qol

    Time frame: 6 months

  5. The score of life quality

    The score of QLQ-C30

    Time frame: 6 months

  6. The score of life quality QLQ-BR23

    The score of QLQ-BR23

    Time frame: 6 months

  7. The incidence of adverse events

    Incidence of adverse outcome events (such as fatigue, malignancy / vomiting, abdominal pain, diarrhea, stomatitis, impaired liver function, bone marrow suppression, etc.)

    Time frame: 6 months

07

Study locations

1 site
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    Guangzhou, Guangdong 510120, China
08

References and documents

Publications

  • Xia Y, Zhu Y, Ling L, Xu F, Yang Y, Ye J, Tan W, Chen Z, Liu Q, Wei W, Zhang J, Zhang A, Zhang L, Song E, Gong C. Effect of methylcobalamin on capecitabine induced hand-foot syndrome in patients with HER2 negative early breast cancer: multicentre, double blind, randomised, placebo controlled, phase 3 trial. BMJ. 2025 Sep 11;390:e084290. doi: 10.1136/bmj-2025-084290. PubMed 40935571 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05165069
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Responsible party
Chang Gong (Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Dec 21, 2021
Start date
Jan 1, 2022
Primary completion
Aug 22, 2024
Completion
Dec 31, 2030 (estimated)
Last update
Feb 2, 2026

Study contacts

Chang Gong
study chair · Sun Yat-sen Memorial Hospital of Sun Yat-sen Univeristy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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