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 in the Appalachian Highlands Region
Led by Charles Mays · Updated on 2026-02-20
100
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
C
Charles Mays
Lead Sponsor
P
Paxman Scalp Cooling
Collaborating Sponsor
AI-Summary
What this Trial Is About
This single-blind, randomized controlled trial is proposed to assess the effects of the PAXMAN Scalp Cooling System on the quality of life of breast cancer subjects receiving any treatment regimen consisting of a chemotherapy agent known to cause chemotherapy-induced alopecia (CIA). Quality of life will be measured using the Chemotherapy-Induced Alopecia Distress Scale (CADS) for cancer patients pre-and post-treatment. Simultaneously, the effect of scalp cooling on hair retention and regrowth will be determined by self-reported grading of photographic assessment using the Alopecia (Hair Loss) Pictorial Tool. Results will be correlated with presence of single nucleotide variations (SNVs) rs3820706 in the CACNB4 gene and rs1202179 in the ABCB1 gene. Participants will be blinded to genetic results until the completion of the study to prevent bias, as knowing results could influence the participants' behavior.
CONDITIONS
Official 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
- Documented informed consent obtained with full confidentiality and voluntary participation
You will not qualify if you...
- Diagnosis of stage IV breast cancer
- Planning to shave hair to the skin during chemotherapy (haircuts or trims allowed if they do not affect hair density analysis)
- 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
- Presence of scalp lesions or pain that could be worsened by the scalp cooling cap
AI-Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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