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

NCT07422376 | Recruiting FDA Device

• 1 other identifier: 2025-149
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alopecia

Outcome Measures

Primary Outcomes (2)

• Hair Retention and Regrowth

  To determine whether the PAXMAN Scalp Cooling System is effective for improving the quality of life of breast cancer subjects in the Appalachian Highlands region. The Self-Reported Alopecia (Hair Loss) Pictorial Tool will be performed to specifically evaluate hair retention and regrowth (on Day 1 and post-treatment 4 weeks (± 1 week), 8 weeks (± 1 week), and 12 weeks (± 1 week)). Grading will be for 0 to 2, with 0 being No Significant Hair Loss, 1 being Hair Loss up to 50%, and 2 being Hair Loss \> 50% as judged by the participant (and referred to as self-reported).

  From enrollment to 12 weeks post-treatment with chemotherapy

• Hair Retention and Chemotherapy-Induced Alopecia Distress

  To determine whether the PAXMAN Scalp Cooling System is effective for improving the quality of life of breast cancer subjects in the Appalachian Highlands region. The Chemotherapy-Induced Alopecia Distress Scale (CADS) will be used to evaluate quality of life on Day 1 and post-treatment 12 weeks (± 1 week). The CADS assesses the psychosocial impact of hair loss due to chemotherapy, helping to understand a patient's level of psychological distress. It specifically measures various aspects of a patient's well-being, including physical, emotional, activeness, and relationship distress. The CADS is a 17-item self-report questionnaire that uses a four-point Likert scale (0 = Not at All, 1 = A Little, 2 = Quite a Bit, 3 = Very Much). The total score can range from 0 to 51, with higher scores indicating greater distress. Scores from 0 to 13 indicate low levels of distress, while scores of 14 or above indicate a high level of distress related to chemotherapy-induced alopecia.

  From enrollment to 12 weeks post-treatment with chemotherapy

Secondary Outcomes (1)

• Role of Single Nucleotide Variations

  From enrollment to 12 weeks post-treatment with chemotherapy

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Receiving CIA treatment with the PAXMAN Scalp Cooling System

Device: Paxman Scalp Cooling System

Control Arm

NO INTERVENTION

No hair retention treatment

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with a diagnosis of stage I - III breast cancer, with planned therapy using any anthracycline- or taxane-based regimen.
• Age ≥18 years

You may not qualify if:

• Stage IV disease
• Patients planning to shave their hair to the skin during chemotherapy treatment. Haircuts or trims will be permitted if they do not inhibit hair density analysis.
• Intolerance to the PAXMAN Scalp Cooling System, including any contraindicated situations (i.e., hematological malignancies, cold urticarial, cold agglutinin disease, scalp metastases, any planned bone marrow ablation chemotherapy, and/or any skull irradiation).
• Scalp lesions or pain that would be exacerbated by the PAXMAN Scalp Cooling cap.

Sponsors & Collaborators

• Charles Mays: lead
• Paxman Scalp Cooling: collaborator

Study Sites (1)

Ballad Health Cancer Care

Kingsport, Tennessee, 37660, United States

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Charles E Mays, PhD, CCRP, CCRC

CONTACT

4234315654; charles.mays@balladhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research, SW Market

Model Details: single-blind, randomized

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 20, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)