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

November 26, 2021 updated by: Tao OUYANG

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yingping Dong, Bachelor
  • Phone Number: 4002 0086-10-88271119
  • Email: qqyyapp@sohu.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Peking University Cancer Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: scalp cooling system
'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.
Device: Scalp cooling system
Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward. Temperature of scalp cooling system can be controlled constantly, the effect of reducing scalp temperature maybe better and patient tolerance maybe better. Meanwhile, there is a higher likelihood of hair retention due to a tight fit in scalp cooling system.
Other Names:
  • DigniCap
Active Comparator: cold cap
'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.
Device: Cold cap
The operation of chemical cold cap is convenient and the price was low, and the economic burden of patients was not increased. But it is necessary to replace the cold cap periodically during chemotherapy, and the temperature during chemotherapy is difficult to keep constant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effects on the prevention of alopecia of two methods
Time Frame: 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.
One year after neoadjuvant chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualify of life
Time Frame: 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.
One year after neoadjuvant chemotherapy
Psychological stress
Time Frame: 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.
One year after neoadjuvant chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tao OUYANG

Investigators

  • Study Director: Xinying Yu, Master, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCP-25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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