Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)
NCT ID: NCT03711877
Last Updated: 2021-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
256 participants
INTERVENTIONAL
2019-03-07
2023-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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scalp cooling system
'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.
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.
cold cap
'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Tao OUYANG
OTHER
Responsible Party
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Tao OUYANG
Director of Breast Center of Peking University Cancer Hospital
Principal Investigators
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Xinying Yu, Master
Role: STUDY_DIRECTOR
Peking University Cancer Hospital & Institute
Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xinying Yu, Master
Role: primary
Yingping Dong, Bachelor
Role: backup
Other Identifiers
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BCP-25
Identifier Type: -
Identifier Source: org_study_id