Scalp Cooling in MBC

Description

This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The name of the study intervention involved in this study is: * Paxman Scalp Cooling System

Conditions

Metastatic Breast Cancer, Chemotherapy-induced Alopecia

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Study Overview

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Study Details

Study overview

This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. The name of the study intervention involved in this study is: * Paxman Scalp Cooling System

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

Scalp Cooling in MBC

Condition
Metastatic Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2
  • * Participant is ≥ 18 years old.
  • * Hair present at baseline.
  • * One of the following full dose chemotherapy regimens must be planned for at least 4 cycles:
  • * Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle
  • * Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks
  • * Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle
  • * The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group.
  • * Known hematological malignancies (i.e. leukemia or lymphoma)
  • * Known scalp metastases.
  • * Baseline alopecia (defined CTCAE 5.0 grade \> 0, see Appendix B)
  • * Subjects with cold agglutinin disease or cold urticaria.
  • * Subjects who are scheduled for bone marrow ablation chemotherapy.
  • * 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, the subject may go on study at the discretion of the Principal Investigator.
  • * Subjects who have lichen planus or lupus.
  • * Participants who are receiving any additional anti-cancer agents

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dana-Farber Cancer Institute,

Elahe Salehi, DNP, ANP-BC, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

2028-06-01