Using scalp cooling to reduce chemotherapy hair loss and protect quality of life for breast cancer patients
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
This trial will test whether the PAXMAN scalp cooling system helps adults with stage I–III breast cancer keep more hair and feel better during anthracycline- or taxane-based chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ballad Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Kingsport, Tennessee) |
| Trial ID | NCT07422376 on ClinicalTrials.gov |
What this trial studies
This single-blind, randomized controlled trial will enroll 100 adults with stage I–III breast cancer in the Appalachian Highlands region and randomize them 1:1 to receive scalp cooling with the PAXMAN system or no hair retention treatment during chemotherapy. Quality of life related to hair loss will be measured before and after treatment using the Chemotherapy-Induced Alopecia Distress Scale (CADS), and hair retention/regrowth will be rated by participants using a photographic pictorial tool. Blood samples will be analyzed for two single nucleotide variations (rs3820706 in CACNB4 and rs1202179 in ABCB1) to explore genetic links with hair loss and regrowth, with genetic results withheld from participants until study completion. The trial is conducted at Ballad Health Cancer Care in Kingsport, Tennessee, and participants must be able to receive their chemotherapy at the study site.
Who should consider this trial
Good fit: Adults (age ≥18) with stage I–III breast cancer planning anthracycline- or taxane-based chemotherapy, willing to consent, avoid shaving during treatment, and receive care at the study site are eligible.
Not a fit: Patients with stage IV disease, those planning to shave their hair to the skin during treatment, or those with contraindications to scalp cooling (for example hematologic malignancies, cold urticaria, cold agglutinin disease, or scalp metastases) are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, scalp cooling could reduce chemotherapy-induced hair loss and improve patients' quality of life, and genetic markers might help predict who benefits most.
How similar studies have performed: Scalp cooling devices like PAXMAN have prior clinical evidence showing reduced chemotherapy-related hair loss, while using specific SNVs to predict hair retention is a novel and exploratory component.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kingsport, Tennessee
- Ballad Health Cancer Care — Kingsport, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Charles E Mays, PhD, CCRP, CCRC
- Email: charles.mays@balladhealth.org
- Phone: 4234315654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.