Scalp Cooling in MBC
NCT04986579 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-11-19
Summary
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
Interventions
- DEVICE
-
Paxman Scalp Cooling System
Cap attached to coolant lines connected to a refrigeration unit placed on scalp
- DRUG
-
Eribulin
Intravenous Infusion
- DRUG
-
Intravenous Infusion
- DRUG
-
Intravenous Infusion
Sponsors & Collaborators
-
Paxman Coolers Limited
collaborator UNKNOWN - collaborator INDUSTRY
-
Eisai Inc.
collaborator INDUSTRY - collaborator INDUSTRY
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Elahe Salehi, DNP, ANP-BC · Dana-Farber Cancer Institute
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-07
- Primary Completion
- 2026-06-01
- Completion
- 2028-06-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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