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

Phase 3

• Conditions: Primary Breast Cancer
• Interventions: Device: Cold cap; Device: Scalp cooling system

• Registration Number: NCT03711877
• Lead Sponsor: Tao OUYANG

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.

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-16
• Study First Posted: 2018-10-19
• Study Start: 2019-03-07
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-11-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cold cap	Cold cap	'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.
scalp cooling system	Scalp cooling system	'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.

Primary Outcome Measures

Name	Time	Method
The effects on the prevention of alopecia of two methods	One year after neoadjuvant chemotherapy	To compare the effects of scalp cooling system and chemical cold cap on the prevention of chemotherapy-induced alopecia in breast cancer patients undergoing neoadjuvant chemotherapy containing anthracycline followed paclitaxel. To assess hair status, a total of three photographs of patients'hair in the both groups were taken by study personnel before the start of first chemotherapy cycle, within 2 days before the start of paclitaxel chemotherapy and within 1 week after the last chemotherapy cycle. Photographs captured hair from the top of head. Patients assessed and estimated the percentage of hair loss using WHO classification of acute and subacute toxicity of anticancer drugs. Success was defined as WHO criteria alopecia grade I (\<25% hair loss) or grade II (25%-50% hair loss). Failure was defined as WHO criteria alopecia grade III (\>50% hair loss) or grade IV. The primary efficacy end point was assessed by clinicians who were independent.

Secondary Outcome Measures

Name	Time	Method
Qualify of life	One year after neoadjuvant chemotherapy	To compare the effects of scalp cooling system and chemical cold cap on the quality of life. Quality of life was measured using the European Organization for Research and Treatment of Cancer Breast CancerSpecific Quality of Life Questionnaire-Core 30（EORTC QLQ-C30） administered at baseline and at the time of the last chemotherapy cycle.
Psychological stress	One year after neoadjuvant chemotherapy	The Hospital Anxiety and Depression Scale (HADS) administered at baseline and at the time of the last chemotherapy cycle was used to assess anxiety and depression.

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China