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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Cooler Heads Care Inc.
Study ID
NCT05484973
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMMA Portalbe Scalp Cooling System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 8, 2024
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
99 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: All patients will use AMMA
    Device: 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.

Primary Outcome Measure

Hair Loss [ Time Frame: 3 Weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona245024
Sima Ehsani, MD
[email protected]
520-621-2449
Carle HealthUrbanaIllinois61801
Maria Perdekamp, MD
[email protected]
217-300-5700

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Arizona· Tucson, AZCarle Health· Urbana, IL

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