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 range18 Years – 70 Years

SexFEMALE

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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)
✓. 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

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-22

View on ClinicalTrials.gov More Hand-foot Syndrome trials