Study of AMMA Portable Scalp Cooling System for Hair Loss in Breast Cancer

This study is looking at how well the AMMA Portable Scalp Cooling System (PSCS) can prevent hair loss in women with early-stage breast cancer who are receiving chemotherapy (CT). The AMMA system is a device you can use at the chemotherapy center, during travel, and at home. Researchers also want to understand how safe and easy the device is to use, and how it affects your quality of life and satisfaction with your hair. You may be able to join if you are a woman at least 21 years old with stage I, II, or III breast cancer, and are scheduled to receive a specific type of chemotherapy. The study will measure hair loss after 3 weeks of treatment. The study is currently enrolling about 99 participants.

Study design
This is a study that will enroll about 99 women with early-stage breast cancer. It is designed to assess the AMMA Portable Scalp Cooling System's ability to prevent hair loss.
What's involved
You would participate in training on how to use the AMMA device. You would bring the device to each chemotherapy visit and use it for 30 minutes before, during, and at least 2.5 hours after chemotherapy. Scalp photos will be taken at the start and after your last chemotherapy treatment.
Compensation
Not stated in the trial record.
Follow-up
Hair loss will be measured at 3 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05484973

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

Recruiting
NAAges 21+InterventionalSupportive care
Cooler Heads Care Inc.
~99 participants
Updated 2025-04-06 on ClinicalTrials.gov
What's tested:AMMA Portalbe Scalp Cooling System

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hair Loss
Measured over 3 Weeks
Alopecia
Chemotherapy-induced Alopecia
Hair Loss
Breast Cancer
2 sites across 2 states
Arizona1
Illinois1
  • Kate Dilligan · PRINCIPAL_INVESTIGATOR · Cooler Heads Inc.

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  • Hair Loss3 Weeks

    To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last CT treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) post-treatment, by photographs, compared to baseline photographs.