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Scalp Cooling for Hair Loss During Breast Cancer Chemotherapy

This study is looking at how well the Paxman Scalp Cooling System works to reduce hair loss (alopecia) and improve quality of life for people with breast cancer undergoing chemotherapy. You could be eligible if you are at least 18 years old, have stage I-III breast cancer, and are receiving certain types of chemotherapy (anthracycline- or taxane-based). The study will measure how much hair you keep and regrow, and how much distress hair loss causes you, from when you start until 12 weeks after your chemotherapy ends. Researchers will also look at how certain genetic differences (single nucleotide variations or SNVs) might affect hair loss and regrowth. The study aims to enroll 100 participants, but its current status is unclear.

Study design
This is a single-blind, randomized controlled study, meaning some participants will receive scalp cooling and others will not, and you won't know which group you're in. It plans to include 100 participants, split into two groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your hair retention and regrowth, and distress from hair loss, will be measured from when you enroll until 12 weeks after your chemotherapy treatment is finished.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07422376

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

Recruiting
NAAges 18+InterventionalTreatment
Charles Mays
~100 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Paxman Scalp Cooling System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hair Retention and Regrowth
Measured over From enrollment to 12 weeks post-treatment with chemotherapy
+1 more outcome measured

Conditions

Alopecia

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Tennessee1

Who to contact

Charles E Mays, PhD, CCRP, CCRC
[email protected]
4234315654
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Hair Retention and RegrowthFrom 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).

  • Hair Retention and Chemotherapy-Induced Alopecia DistressFrom 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.