search
Back to results

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

Primary Purpose

Primary Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Scalp cooling system
Cold cap
Sponsored by
Tao OUYANG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Breast Cancer focused on measuring alopecia, scalp cooling system, cold cap

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

scalp cooling system

cold cap

Arm Description

'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.

'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.

Outcomes

Primary Outcome Measures

The effects on the prevention of alopecia of two methods
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

Qualify of life
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
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.

Full Information

First Posted
October 11, 2018
Last Updated
November 26, 2021
Sponsor
Tao OUYANG
search

1. Study Identification

Unique Protocol Identification Number
NCT03711877
Brief Title
Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)
Acronym
COHAIR
Official Title
Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tao OUYANG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Breast Cancer
Keywords
alopecia, scalp cooling system, cold cap

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
256 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
scalp cooling system
Arm Type
Experimental
Arm Description
'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.
Arm Title
cold cap
Arm Type
Active Comparator
Arm Description
'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.
Intervention Type
Device
Intervention Name(s)
Scalp cooling system
Other Intervention Name(s)
DigniCap
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cold cap
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effects on the prevention of alopecia of two methods
Description
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.
Time Frame
One year after neoadjuvant chemotherapy
Secondary Outcome Measure Information:
Title
Qualify of life
Description
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.
Time Frame
One year after neoadjuvant chemotherapy
Title
Psychological stress
Description
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.
Time Frame
One year after neoadjuvant chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinying Yu, Master
Phone
0086-10-88271119
Ext
8018
Email
cindy1104@sohu.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yingping Dong, Bachelor
Phone
0086-10-88271119
Ext
4002
Email
qqyyapp@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinying Yu, Master
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinying Yu, Master
Phone
0086-10-88271119
Ext
4002
Email
cindy1104@sohu.com
First Name & Middle Initial & Last Name & Degree
Yingping Dong, Bachelor
Email
qqyyapp@sohu.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs