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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
234
Mecobalamin 0.5mg / time, 3 times / day,was taken continuously for 6 months
placebo 0.5mg / time, 3 times / day,was taken continuously for 6 months
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
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
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
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
Overall Survival
The time from the beginning of treatment to the death of the patient caused by any factor
Time frame: 5 year
The score of life quality questionnaire
The score of HF-Qol
Time frame: 6 months
The score of life quality
The score of QLQ-C30
Time frame: 6 months
The score of life quality QLQ-BR23
The score of QLQ-BR23
Time frame: 6 months
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
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