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

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ClinicalTrials.gov Identifier: NCT03711877
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University

Brief Summary:
This is a phase III, single-center, prospective, open-label, randomized,controlled study

Condition or disease Intervention/treatment Phase
Primary Breast Cancer Device: Scalp cooling system Device: Cold cap Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer
Actual Study Start Date : March 7, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


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 Name: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711877


Contacts
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Contact: Xinying Yu, Master 0086-10-88271119 ext 8018 cindy1104@sohu.com
Contact: Yingping Dong, Bachelor 0086-10-88271119 ext 4002 qqyyapp@sohu.com

Locations
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China, Beijing
Peking University Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Xinying Yu, Master    0086-10-88271119 ext 4002    cindy1104@sohu.com   
Contact: Yingping Dong, Bachelor       qqyyapp@sohu.com   
Sponsors and Collaborators
Tao OUYANG
Investigators
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Study Director: Xinying Yu, Master Beijing Cancer Hospital
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Responsible Party: Tao OUYANG, Director of Breast Center of Peking University Cancer Hospital, Peking University
ClinicalTrials.gov Identifier: NCT03711877    
Other Study ID Numbers: BCP-25
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tao OUYANG, Peking University:
alopecia
scalp cooling system
cold cap
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases