NCT04986579

Scalp Cooling in MBC

Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Metastatic Breast Cancer
• Chemotherapy-induced Alopecia

Interventions

Type	Name	Description
DEVICE	Paxman Scalp Cooling System	Cap attached to coolant lines connected to a refrigeration unit placed on scalp
DRUG	Eribulin	Intravenous Infusion
DRUG	Sacituzumab govitecan	Intravenous Infusion
DRUG	Trastuzumab deruxtecan	Intravenous Infusion

Timeline

• Start date: 2021-10-07
• Primary completion: 2026-06-01
• Completion: 2028-06-01
• First posted: 2021-08-03
• Last updated: 2025-11-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study