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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    256
  • sponsor
    Tao OUYANG
Updated on 5 December 2021

Summary

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

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%, =0.05Power=0.8. The sample size was calculated to be at least 128 cases in each group, 256 cases in total.

Details
Condition Primary Breast Cancer
Treatment Scalp cooling system, Cold cap
Clinical Study IdentifierNCT03711877
SponsorTao OUYANG
Last Modified on5 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients, 18age 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
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