RecruitingNot ApplicableNCT05484973

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.


Sponsor

Cooler Heads Care Inc.

Enrollment

99 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a portable scalp cooling device designed to prevent hair loss during chemotherapy. Scalp cooling works by reducing blood flow to hair follicles during treatment, making it harder for the chemotherapy drugs to reach and damage them. **You may be eligible if...** - You are a woman aged 21 or older - You have been diagnosed with Stage I, II, or III breast cancer - You are scheduled to receive a chemotherapy regimen that includes a taxane (paclitaxel or docetaxel) with the goal of curing or reducing your cancer before or after surgery - Your hair has fully recovered from any prior chemotherapy (at least 2 years since the last treatment that caused hair loss) - Your general health status (Karnofsky score) is 80% or higher **You may NOT be eligible if...** - You have significant pre-existing hair loss (female pattern baldness) - You have an autoimmune condition affecting your hair (such as alopecia areata) - You have had whole brain radiation - Your chemotherapy regimen includes an anthracycline (e.g., AC/T, TAC) or does not include paclitaxel or docetaxel - You are taking hormone therapy at the same time as chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAMMA 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.


Locations(2)

University of Arizona

Tucson, Arizona, United States

Carle Health

Urbana, Illinois, United States

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NCT05484973


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