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

Breast Cancer Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT05484973
• Study type: Interventional
• Source: Cooler Heads Care Inc.
• Contact: Chris Schultz, BS
• Phone: 9715067552
• Email: cschultz@ecr-inc.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 31, 2024
• Completion date: September 30, 2025