AlopeciaNCT07422376
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
A study testing Paxman Scalp Cooling System in people with Alopecia, run by Charles Mays at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- Paxman Scalp Cooling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ballad Health Cancer Care
Kingsport, Tennessee, 37660
Charles E Mays, PhD, CCRP, CCRC, 4234315654, charles.mays@balladhealth.org
About this study
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.
Read the 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.
- Conditions
- Alopecia
- Being tested
- Paxman Scalp Cooling System
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxman Scalp Cooling SystemDevice
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 group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Receiving CIA treatment with the PAXMAN Scalp Cooling System Receives: Device: Paxman Scalp Cooling System |
| Control Arm | No intervention | No hair retention treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: From enrollment to 12 weeks post-treatment with chemotherapy
Secondary outcomes (1)
Role of Single Nucleotide Variations
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.
Measured: From enrollment to 12 weeks post-treatment with chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- single-blind, randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles Mays
- Sponsor type
- University, hospital or other
- Collaborators
- Paxman Scalp Cooling
- Responsible party
- Sponsor-investigator, Charles Mays, Ballad Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422376
- Sponsor's protocol ID
- 2025-149
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07422376
- Acronym / sponsor ID
- 2025-149
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Charles MaysUniversity, hospital or other
- Collaborators
- Paxman Scalp Cooling
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: Paxman Scalp Cooling SystemReceiving CIA treatment with the PAXMAN Scalp Cooling System |
| Control Arm | No intervention | –No hair retention treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paxman Scalp Cooling SystemThe 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. | Device | Treatment Arm |
Primary outcome
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).
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.
1 secondary outcome
Role of Single Nucleotide Variations
Time frame: From enrollment to 12 weeks post-treatment with chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paxman Scalp Cooling System in people with Alopecia, run by Charles Mays at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles E Mays, PhD, CCRP, CCRC (4234315654, charles.mays@balladhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Retention and Regrowth (time frame: From enrollment to 12 weeks post-treatment with chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.