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

Part of paid clinical trials in Kingsport, Tennessee.

Sponsor
Charles Mays
Study ID
NCT07422376
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paxman Scalp Cooling System — DEVICE
    The Paxman Scalp Cooling System is a clinically proven medical device designed to prevent or reduce chemotherapy-induced alopecia (hair loss). It is FDA-cleared for use in patients with solid tumors, such as breast, ovarian, and prostate cancers.

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Receiving CIA treatment with the PAXMAN Scalp Cooling System
  • No Intervention: Control Arm
    No hair retention treatment

Primary Outcome Measure

Hair Retention and Regrowth [ Time Frame: From enrollment to 12 weeks post-treatment with chemotherapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ballad Health Cancer CareKingsportTennessee37660
Charles E Mays, PhD, CCRP, CCRC
[email protected]
4234315654

Find similar trials in Kingsport, TN

By research site
Ballad Health Cancer Care· Kingsport, TN

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