NCT05484973

Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Cooler Heads Care Inc. · Other Government
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

Detailed description

This is a prospectively enrolling, post-market, on-label study to assess the ability of the AMMA PSCS to prevent hair loss in women receiving CT for early-stage breast cancer, and to assess the safety, tolerability and compliance, patient quality of life, and satisfaction with hair after treatment. Female patients at least 21 years of age with stage I, II, or III breast cancer who are receiving a taxane-containing CT regimen that is scheduled to be completed within six months will be identified and data from the electronic health record (EHR) as well as prospective data will be collected. AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy treatment.

Conditions

• Alopecia
• Chemotherapy-induced Alopecia
• Hair Loss
• Breast Cancer

Interventions

Type	Name	Description
DEVICE	AMMA Portalbe Scalp Cooling System	AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

Timeline

• Start date: 2024-11-08
• Primary completion: 2026-03-31
• Completion: 2026-09-30
• First posted: 2022-08-02
• Last updated: 2025-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study