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Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180579
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
This study is being done to determine if using the Paxman Scalp Cooling System at temperatures lower than the current standard is a safe and tolerable approach to prevent hair loss in breast cancer patients receiving chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Device: PAXMAN Scalp Cooler Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Safety and Tolerability of Lower Scalp Cooling Temperatures to Prevent Doxorubicin Plus Cyclophosphamide and Paclitaxel-induced Alopecia in Breast Cancer Patients
Actual Study Start Date : November 26, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants with Breast Cancer
Any adult woman with a new diagnosis of breast cancer, Stage I-III
 Device: PAXMAN Scalp Cooler
Scalp cooling will occur with each dose of chemotherapy.


Outcome Measures
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Primary Outcome Measures :
  1. Safety as assessed by CTCAE [ Time Frame: Up to 44 weeks from the start of treatment ]
    Safety will be determined by toxicity assessment according to CTCAE


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • New diagnosis of breast cancer stage I-IV
  • Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent

  • Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen:

    • Concurrent trastuzumab at standard doses is allowed
    • Concurrent pertuzumab at standard doses is allowed
    • Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated
  • For women of childbearing potential, a negative pregnancy test is needed within 7 days prior to study intervention, or whenever collected as per standard of care. For women who undergo fertility preservation or ovarian stimulation, a negative pregnancy test is not needed and eligibility due to positive pregnancy test will be determined by investigator discretion.

Exclusion Criteria:

  • Any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
  • Baseline alopecia (defined CTCAE v5.0 grade > 1)
  • Subjects who are scheduled for bone marrow ablation chemotherapy
  • Male gender
  • Age >/= 75 years
  • Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator.
  • Subjects who have had prior chemotherapy
  • Subjects who have had >/=1 previous chemotherapy exposure resulting in alopecia
  • An existing history of scalp metastases or suspected presence of scalp metastasis
  • Subjects with cold sensitivity, cryoglobulinemia, cryofibrinogenemia, or cold migraine pot-traumatic cold dystrophy
  • Previously received, or scheduled to undergo skull irradiation
Contacts and Locations
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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): NCT04180579


Contacts
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Contact: Shari Goldfarb, MD 646-888-5080 goldfars@mskcc.org
Contact: Mario Lacoutre, MD 646-888-6014 LacoutuM@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Shari Goldfarb, MD    646-888-5080      
Contact: Mario Lacouture, MD    646-888-6014      
Principal Investigator: Shari Goldfarb, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Shari Goldfarb, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04180579    
Other Study ID Numbers: 19-277
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
alopecia
breast cancer
hair loss
 chemotherapy induced alopecia
19-277
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases