Spots Global Cancer Trial Database for Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)

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Trial Identification

Brief Title: Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)

Official Title: Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer

Study ID: NCT03711877

Conditions

Primary Breast Cancer

Interventions

Scalp cooling system

Cold cap

Study Description

Brief Summary: This is a phase III, single-center, prospective, open-label, randomized,controlled study

Detailed Description: To conduct a prospective randomized controlled study comparing the effect of scalp cooling system (DigniCap) and chemical cold cap on preventing chemotherapy-induced alopecia in a group of breast cancer patients receiving standard anthracycline followed paclitaxel regimens. To obtain the exact data on the role of different methods of preventing alopecia in Chinese women with breast cancer. PASS 11 software was used to calculate the sample size. According to the results of previous studies, the hair retention rate of the cold cap group was 67.7%, the hair retention rate of the scalp cooling system group was 50.5%, α=0.05，Power=0.8. The sample size was calculated to be at least 128 cases in each group, 256 cases in total.