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

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

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

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.

Inclusion Criteria:

• Female patients, 18≦age ≦66 years
• Invasive breast cancer diagnosed with core needle needle biopsy
• Staging I-II
• Without chemotherapy contraindications, and planned to receive neoadjuvant chemotherapy with a standard regimen (containing 4-cycle dose-dense anthracycline followed 4-cycle paclitaxel)
• Attend the study voluntarily, sign the informed consent

Exclusion Criteria:

• History of malignant tumors
• With chemotherapy contraindications
• With severe dermatosis and severe sparsity
• History of chronic diseases such as cerebrovascular disease, migraine and hyperthyroidism
• Uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection
• Refuse to join the study