The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome (NCT05165069) | Clinical Trial Compass
Active — Not RecruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
China234 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of grade 2 / 3 hand foot syndrome
Timeframe: 6 months
Trial details
NCT IDNCT05165069
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
. Blood routine examination was basically normal within 4 weeks before enrollment: A. white blood cell count (WBC) ≥ 3.0 × 10 \^ 9 / L, B. medium
. 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
Exclusion criteria
. 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.
. Any accompanying disease or condition that may interfere with the study, or any serious medical impairment that may affect the safety of the subject
. 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.