Scalp Cooling in MBC
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- STATUS
- Recruiting
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- End date
- Jun 1, 2026
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- participants needed
- 120
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- sponsor
- Dana-Farber Cancer Institute
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
Description
This study is a prospective, controlled, pivotal clinical investigation to assess the efficacy of the Paxman Scalp Cooling System (PSCS) at preventing hair loss in people undergoing treatment for metastatic breast cancer with either Sacituzumab govitecan (IMMU-132 or Trodelvy™), trastuzumab deruxtecan (DS-8201a or Enhertu®), or Eribulin (Halaven®).
The U.S. Food and Drug Administration (FDA) has approved the Paxman Scalp Cooling System as a treatment option for preventing hair loss while patients are undergoing chemotherapy. This system has however not been specifically studied to look at its ability to prevent hair loss in patients specifically receiving sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.
The research study procedures include: screening for eligibility, photographs, hair loss assessments, questionnaires and study treatment including evaluations and follow up visits.
Participants will receive study treatment with scalp cooling with standard of care chemotherapy treatment and will be followed for 2-4 weeks after completion of treatment with chemotherapy.
It is expected that about 120 people will take part in this research study.
Paxman Coolers Limited is a medical device company and is supporting this research study by providing access to the investigational device, Paxman Scalp Cooling System.
Details
| Condition | Metastatic Breast Cancer, Chemotherapy-induced Alopecia |
|---|---|
| Treatment | Eribulin, Sacituzumab govitecan, Trastuzumab deruxtecan, Paxman Scalp Cooling System |
| Clinical Study Identifier | NCT04986579 |
| Sponsor | Dana-Farber Cancer Institute |
| Last Modified on | 23 March 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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