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

February 12, 2026 updated by: Charles Mays
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

100 subjects, 50 per cohort: 1) Treatment Arm - receiving CIA treatment with the PAXMAN Scalp Cooling System and 2) Control Arm - No hair retention treatment.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients with a diagnosis of stage I - III breast cancer, with planned therapy using any anthracycline- or taxane-based regimen.
  • Age ≥18 years
  • A documented informed consent will be obtained prior to inclusion in the study. All discussions with patients will be held in strictest confidence and out of earshot of the general public. Patients will be fully informed that their participation in the study is voluntary. Patients may decline to be part of the study. Their decision to participate in the study will not affect the care they receive.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Receiving CIA treatment with the PAXMAN Scalp Cooling System
Device: Paxman Scalp Cooling System
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.
No Intervention: Control Arm
No hair retention treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hair Retention and Regrowth
Time Frame: From enrollment to 12 weeks post-treatment with chemotherapy
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
Time Frame: From enrollment to 12 weeks post-treatment with chemotherapy
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of Single Nucleotide Variations
Time Frame: From enrollment to 12 weeks post-treatment with chemotherapy
To determine the incidence rate and relevance of single nucleotide variations (SNVs) previously linked to CIA in Japanese and Spanish populations for the Appalachian Highlands region of the southeastern United States by sequencing analysis of rs3820706 in the CACNB4 gene and rs1202179 in the ABCB1 gene prior to chemotherapy treatment for all participants.
From enrollment to 12 weeks post-treatment with chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles Mays

Collaborators

Paxman Scalp Cooling

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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