Recruiting

PAXMAN Scalp Cooling

Sponsor:

Charles Mays

Code:

NCT07422376

Conditions

Alopecia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paxman Scalp Cooling System

Study Details

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

Study ID

NCT07422376

Start date

Mar 1, 2026

Status verified date

Feb, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Receiving CIA treatment with the PAXMAN Scalp Cooling System

no intervention: Control Arm

No hair retention treatment

Interventions

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.

Primary outcome measure

  • Hair Retention and Regrowth [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Charles E Mays, PhD, CCRP, CCRC

4234315654charles.mays@balladhealth.org

Locations

Ballad Health Cancer Care

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Charles E Mays, PhD, CCRP, CCRC

4234315654charles.mays@balladhealth.org

More Information

Sponsor

Charles Mays

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Charles Mays on 2026-02-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.