Primary Breast CancerPhase 3COHAIRNCT03711877
Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)
A Phase 3 study testing Scalp cooling system and Cold cap in people with Primary Breast Cancer, run by Tao OUYANG at 1 site in China.
Trial summary
This is a phase III, single-center, prospective, open-label, randomized,controlled study Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Scalp cooling system and Cold cap
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2019to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Xinying Yu, Master, 0086-10-88271119 ext. 4002, cindy1104@sohu.com
Yingping Dong, Bachelor, qqyyapp@sohu.com
About this study
Official title: 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
Read the 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.
- Conditions
- Primary Breast Cancer
- Being tested
- Scalp cooling system, Cold cap
- Keywords
- alopecia, scalp cooling system, cold cap
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp cooling systemDevice
Also called DigniCap
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.
Cold capDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| scalp cooling system | Experimental | 'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion. Receives: Device: Scalp cooling system |
| cold cap | Active comparator | 'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion. Receives: Device: Cold cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year after neoadjuvant chemotherapy
Secondary outcomes (2)
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.
Measured: One year after neoadjuvant chemotherapy
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.
Measured: One year after neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start7 Mar 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao OUYANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao OUYANG, Peking University
- Investigators
- Xinying Yu, Master, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711877
- Sponsor's protocol ID
- BCP-25
- Acronym
- COHAIR
- Status last verified
- Nov 2021
- First submitted
- 11 Oct 2018
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Wang L, He Y, Sun H, Niu J, Duan M, Miao C, Li J, Cao W, Wang X, Wang X, Yang Y, Fan Z, Yu X. Efficacy of scalp cooling system versus chemical cooling cap in preventing chemotherapy-induced alopecia in breast cancer (COHAIR Study): a prospective randomized trial. Breast. 2026 Jun;87:104784. doi: 10.1016/j.breast.2026.104784. Epub 2026 Apr 2.
PubMed 41955993
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT03711877
- Acronym / sponsor ID
- COHAIR / BCP-25
- Conditions
- Primary Breast Cancer
- Keywords
- alopecia, scalp cooling system, cold cap
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Tao OUYANGUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| scalp cooling system | Experimental | Device: Scalp cooling system'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion. |
| cold cap | Active comparator | Device: Cold cap'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp cooling systemAlso: DigniCapScalp 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. | Device | scalp cooling system |
| Cold capThe 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. | Device | cold cap |
Primary outcome
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.
2 secondary outcomes
Qualify of life
Time frame: One year after neoadjuvant chemotherapy
Psychological stress
Time frame: One year after neoadjuvant chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Derived from this study: PubMed 41955993Zhang J, Wang L, He Y, Sun H, Niu J, Duan M, Miao C, Li J, Cao W, Wang X, Wang X, Yang Y, Fan Z, Yu X. Efficacy of scalp cooling system versus chemical cooling cap in preventing chemotherapy-induced alopecia in breast cancer (COHAIR Study): a prospective randomized trial. Breast. 2026 Jun;87:104784. doi: 10.1016/j.breast.2026.104784. Epub 2026 Apr 2.
Related trials for Primary Breast Cancer
RecruitingObservational study
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Mastectomy, Breast Neoplasm Malignant Primary
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
Recruiting
Researching the Effect of Exercise on Cancer
Breast Cancer, Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinying Yu, Master study director
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Scalp cooling system and Cold cap in people with Primary Breast Cancer, run by Tao OUYANG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinying Yu, Master (0086-10-88271119 ext. 8018, cindy1104@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effects on the prevention of alopecia of two methods (time frame: One year after neoadjuvant chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03711877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021; AzTrials last refreshed its copy on 6 Nov 2026.