Actively Recruiting
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Led by Cooler Heads Care Inc. · Updated on 2025-04-06
99
Participants Needed
2
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 21 years of age or older
- Diagnosed with breast cancer stage I, II, or III
- Scheduled to receive a taxane-containing chemotherapy regimen with curative intent
- Concomitant agents may include trastuzumab, pertuzumab, cyclophosphamide, or carboplatin
- 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 higher
- Able and willing to sign informed consent
- Able and willing to complete all study procedures
You will not qualify if you...
- Female pattern baldness at or beyond picture I-3 on the Savin scale
- Autoimmune diseases affecting hair, such as alopecia areata or systemic lupus with hair loss
- History of whole brain radiation
- Planned chemotherapy regimens excluding paclitaxel or docetaxel, or including anthracyclines
- Hormone therapy concurrent with chemotherapy (post-chemotherapy hormone therapy allowed)
- Current or prior use of hair growth products like Nutrafol, minoxidil, or Keranique
- Serious infections or medical illnesses that prevent completing therapy and follow-up
- History of persistent grade 2 or higher chemotherapy-induced alopecia
- Exposure to other agents causing hair loss
- Cold sensitivity
- Life-threatening malignancy
- Untreated or poorly controlled thyroid disorders
- History or diagnosis of cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
- Concurrent hematologic malignancy
- Participation in other clinical investigations
- Concurrent treatment with investigational agents
- Any reason investigator considers the patient unsuitable for the study
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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