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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

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date October 28, 2020
Actual Study Start Date  ICMJE March 7, 2019
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Scalp Cooling System and Chemical Cold Cap (COHAIR Study)
Official Title  ICMJE Comparative Study of Scalp Cooling System and Chemical Cold Cap on Prevention of Chemotherapy-induced Alopecia in Women With Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Primary Breast Cancer
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: scalp cooling system
    'Scalp cooling device' will be used to prevent alopecia during chemotherapy regimen infusion.
    Intervention: Device: Scalp cooling system
  • Active Comparator: cold cap
    'Cold cap' will be used to prevent alopecia during chemotherapy regimen infusion.
    Intervention: Device: Cold cap
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 16, 2018)
256
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xinying Yu, Master 0086-10-88271119 ext 8018 cindy1104@sohu.com
Contact: Yingping Dong, Bachelor 0086-10-88271119 ext 4002 qqyyapp@sohu.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03711877
Other Study ID Numbers  ICMJE BCP-25
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tao OUYANG, Peking University
Study Sponsor  ICMJE Tao OUYANG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xinying Yu, Master Beijing Cancer Hospital
PRS Account Peking University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP