Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)
COHAIR
1 other identifier
interventional
256
1 country
1
Brief Summary
This is a phase III, single-center, prospective, open-label, randomized,controlled study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2019
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedStudy Start
First participant enrolled
March 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 29, 2021
November 1, 2021
4.8 years
October 11, 2018
November 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
One year after neoadjuvant chemotherapy
Secondary Outcomes (2)
Qualify of life
One year after neoadjuvant chemotherapy
Psychological stress
One year after neoadjuvant chemotherapy
Study Arms (2)
scalp cooling system
EXPERIMENTAL'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.
cold cap
ACTIVE COMPARATOR'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tao OUYANGlead
Study Sites (1)
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xinying Yu, Master
Peking University Cancer Hospital & Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Breast Center of Peking University Cancer Hospital
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 19, 2018
Study Start
March 7, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
November 29, 2021
Record last verified: 2021-11