Actively Recruiting
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
Led by Cooler Heads Care Inc. · Updated on 2025-04-06
99
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Portable Scalp Cooling System (AMMA PSCS) to prevent hair loss in women undergoing chemotherapy for early-stage breast cancer (stages I-III). This prospective, multi-center study also aims to assess the safety, tolerability, patient compliance, quality of life, and satisfaction with hair preservation after chemotherapy treatment. The study focuses on women receiving taxane-containing chemotherapy regimens intended to be completed within six months. The AMMA device is designed for use during chemotherapy infusion, transport from the infusion center to home, and at home. Patients will be trained to use the device and asked to bring it to each chemotherapy session. The device is used 30 minutes before chemotherapy starts, throughout the chemotherapy infusion, and for at least 2.5 hours after the treatment. Scalp photos will be taken at the start and after the last chemotherapy session to evaluate hair loss. Participants will be monitored through electronic health records and prospective data collection. Assessments include safety evaluations, scalp changes, patient symptoms, and tolerability, along with patient-reported outcomes on hair loss, satisfaction, and quality of life using standard scales. The primary outcome is hair loss measured three weeks after treatment, with additional follow-up on device-related effects and patient quality of life. The study will continue until at least three weeks after the last chemotherapy treatment.
CONDITIONS
Brief Title
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 21 years or older
- Diagnosed with stage I, II, or III breast cancer
- Planned taxane-containing chemotherapy regimen with curative intent
- Concomitant use of trastuzumab, pertuzumab, cyclophosphamide, or carboplatin allowed
- Plan to complete chemotherapy regimen within six months
- At least two years since last chemotherapy causing hair loss with full hair recovery
- Karnofsky performance status of 80% or greater
- Willing and able to provide informed consent
- Willing and able to complete all required study procedures
You will not qualify if you...
- Female pattern baldness resembling picture I-3 or higher on the Savin scale
- Autoimmune diseases affecting hair, such as alopecia areata or lupus with hair loss
- History of whole brain radiation
- Planned chemotherapy regimens not containing paclitaxel or docetaxel, or including anthracyclines
- Hormone therapy concurrent with chemotherapy (allowed after chemotherapy completion)
- Current or prior use of hair growth products like Nutrafol, minoxidil, or Keranique
- Serious infections or medical illnesses jeopardizing therapy completion
- History of persistent grade 2 or higher chemotherapy-induced alopecia
- Exposure to other agents causing hair loss
- Cold sensitivity or disorders like cold agglutinin disease
- Untreated or poorly controlled thyroid disorders
- Concurrent hematologic malignancy
- Participation in other clinical studies or treatment with investigational agents
- Investigator judgment deeming patient unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months, corresponding to the chemotherapy regimen duration
Participants use the AMMA Portable Scalp Cooling System during each chemotherapy treatment to reduce hair loss. The device is used 30 minutes before chemotherapy, during chemotherapy, and for at least 2.5 hours after chemotherapy at the infusion center, during transport home, and at home.
Chemotherapy treatment visits with device use at each session
Trial Site Locations
Total: 2 locations
1
University of Arizona
Tucson, Arizona, United States, 245024
Actively Recruiting
2
Carle Health
Urbana, Illinois, United States, 61801
Actively Recruiting
Research Team
C
Chris Schultz, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here