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

NCT05165069 | Active Not Recruiting Phase 3

• 1 other identifier: 2020-KY-007
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand-foot Syndrome

Keywords

Hand-foot Syndrome, Mecobalamin, Capecitabine, Breast Cancer

Outcome Measures

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

  6 months

Secondary Outcomes (7)

• The reduction or withdrawal rate of capecitabine

  6 months

• Disease Free Survival

  5 years

• Overall Survival

  5 year

• The score of life quality questionnaire

  6 months

• The score of life quality

  6 months

Study Arms (2)

Mecobalamin group

EXPERIMENTAL

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

Drug: Mecobalamin 5 MG Disintegrating Oral Tablet

Placebo group

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Mecobalamin 5 MG Disintegrating Oral Tablet DRUG

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

Mecobalamin group

placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 18 to 75
• Her-2 negative patients with non metastatic breast cancer.
• patients with early breast cancer who did not receive PCR after neoadjuvant chemotherapy or patients with lymph node metastasis after breast cancer surgery.
• 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)
• Eastern cancer cooperation group (ECoG) physical strength score 0-1;
• 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);
• 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;
• 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；
• 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

You may not qualify if:

• 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.);
• 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);
• there are diseases affecting skin: diabetes, dermatomyositis, sclerosing disease, lupus erythematosus and so on.
• Known history of psychotropic substance abuse or drug abuse;
• Pregnant or lactating patients;
• Inability to swallow, intestinal obstruction or other factors affecting drug administration and absorption.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• 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.

  PMID: 40935571 DERIVED

MeSH Terms

Conditions

Hand-Foot Syndrome; Breast Neoplasms

Interventions

mecobalamin

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Chang Gong

  Sun Yat-sen Memorial Hospital of Sun Yat-sen Univeristy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2022
• Primary Completion: August 22, 2024
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (1)