Actively Recruiting
Evaluation of Scalp Cooling During Chemotherapy on Quality of Life and the Potential Role of Single Nucleotide Variations on Chemotherapy-Induced Alopecia and Hair Regrowth
Led by Charles Mays · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Charles Mays
Lead Sponsor
P
Paxman Scalp Cooling
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the PAXMAN Scalp Cooling System on the quality of life of breast cancer patients receiving chemotherapy known to cause hair loss, called chemotherapy-induced alopecia (CIA). This single-blind, randomized controlled trial will measure quality of life using the Chemotherapy-Induced Alopecia Distress Scale (CADS) before and after treatment. The study will also assess hair retention and regrowth through self-reported photographic assessments and explore genetic factors related to hair loss using specific single nucleotide variations (SNVs). Participants will not know their genetic results until the study ends to avoid bias. The study involves 100 participants divided into two groups: one group will use the PAXMAN Scalp Cooling System during chemotherapy to reduce hair loss, while the other group will receive no hair retention treatment. The device is designed to cool the scalp during treatment to help prevent or reduce hair loss. The study period includes treatment and follow-up lasting up to 12 weeks after chemotherapy ends. Participants will complete assessments of hair retention, hair regrowth, and distress related to hair loss from enrollment through 12 weeks post-chemotherapy. Genetic testing will be done to identify variations that may influence hair loss and regrowth. Researchers will monitor and record these outcomes to understand the impact of scalp cooling on quality of life and hair preservation during cancer treatment.
CONDITIONS
Brief Title
Evaluation of Scalp Cooling During Chemotherapy on Quality of Life and the Potential Role of Single Nucleotide Variations on Chemotherapy-Induced Alopecia and Hair Regrowth in the Appalachian Highlands Region
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage I to III breast cancer with planned anthracycline- or taxane-based chemotherapy
- Age 18 years or older
- Provided documented informed consent before joining the study
- Participation is voluntary and confidential
You will not qualify if you...
- Stage IV breast cancer
- Planning to shave hair to the skin during chemotherapy
- Intolerance or contraindications to the PAXMAN Scalp Cooling System, including hematological malignancies, cold urticarial, cold agglutinin disease, scalp metastases, planned bone marrow ablation chemotherapy, or skull irradiation
- Scalp lesions or pain worsened by use of the scalp cooling cap
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.
1 visit (in-person)
Duration - Duration of chemotherapy treatment
Participants receive chemotherapy with or without the Paxman Scalp Cooling System device to prevent or reduce chemotherapy-induced hair loss.
Visits aligned with chemotherapy sessions
Duration - 12 weeks post-treatment
Participants are monitored for hair retention, hair regrowth, and quality of life for 12 weeks after completing chemotherapy.
Periodic visits during 12 weeks post-treatment
Trial Site Locations
Total: 1 location
1
Ballad Health Cancer Care
Kingsport, Tennessee, United States, 37660
Actively Recruiting
Research Team
C
Charles E Mays, PhD, CCRP, CCRC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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