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Hand-foot SyndromePhase 3NCT05165069

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

A Phase 3 study testing Mecobalamin 5 MG Disintegrating Oral Tablet in people with Hand-foot Syndrome, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Hand-foot Syndrome
What is being tested?
Mecobalamin 5 MG Disintegrating Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
1 siteChina
Study dates
1 Jan 2022to 31 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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
  • Use a medically recognized high-efficiency contraceptive during and within 6 months after the last administration of the drug;
  • Informed consent has been signed before joining the group;
  • There was no active infectious disease within 12 weeks of screening period

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome in Breast Cancer Patients: A Multicenter, Phase III, Randomized, Double-blind, Controlled Trial

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.

Being tested
Mecobalamin 5 MG Disintegrating Oral Tablet, placebo
Keywords
Hand-foot Syndrome, Mecobalamin, Capecitabine, Breast Cancer
Medical subject headings
Hand-Foot Syndrome, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mecobalamin 5 MG Disintegrating Oral TabletDrug

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

  • placeboDrug

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

Study groups in NCT05165069
Study groupRoleWhat they receive
Mecobalamin groupExperimentalMecobalamin (0.5mg / time, 3 times / day) for 6 months
Receives: Drug: Mecobalamin 5 MG Disintegrating Oral Tablet
Placebo groupPlacebo comparatorplacebo (0.5mg / time, 3 times / day) for 6 months
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (7)

  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

    Measured: 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

    Measured: 5 years

  3. Overall Survival

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

    Measured: 5 year

  4. The score of life quality questionnaire

    The score of HF-Qol

    Measured: 6 months

  5. The score of life quality

    The score of QLQ-C30

    Measured: 6 months

  6. The score of life quality QLQ-BR23

    The score of QLQ-BR23

    Measured: 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.)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2021
  2. Study start1 Jan 2022
  3. Primary completion22 Aug 2024
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05165069
Sponsor's protocol ID
2020-KY-007
Status last verified
Jan 2026
First submitted
15 Dec 2021
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mecobalamin 5 MG Disintegrating Oral Tablet in people with Hand-foot Syndrome, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of grade 2 / 3 hand foot syndrome (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05165069, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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