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

Primary Purpose

Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAXMAN Scalp Cooler
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring alopecia, breast cancer, hair loss, chemotherapy induced alopecia, 19-277, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants with Breast Cancer

Arm Description

Any adult woman with a new diagnosis of breast cancer, Stage I-III

Outcomes

Primary Outcome Measures

Safety as assessed by CTCAE
Safety will be determined by toxicity assessment according to CTCAE

Secondary Outcome Measures

Full Information

First Posted
November 26, 2019
Last Updated
July 31, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04180579
Brief Title
Safety of Lower Scalp Cooling Temperature to Prevent Hair Loss From Chemotherapy in Breast Cancer Patients
Official Title
Safety and Tolerability of Lower Scalp Cooling Temperatures to Prevent Doxorubicin Plus Cyclophosphamide and Paclitaxel-induced Alopecia in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2019 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
Keywords
alopecia, breast cancer, hair loss, chemotherapy induced alopecia, 19-277, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participants with Breast Cancer
Arm Type
Experimental
Arm Description
Any adult woman with a new diagnosis of breast cancer, Stage I-III
Intervention Type
Device
Intervention Name(s)
PAXMAN Scalp Cooler
Intervention Description
Scalp cooling will occur with each dose of chemotherapy.
Primary Outcome Measure Information:
Title
Safety as assessed by CTCAE
Description
Safety will be determined by toxicity assessment according to CTCAE
Time Frame
Up to 44 weeks from the start of treatment

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari Goldfarb, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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

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