Using scalp cooling to reduce chemotherapy hair loss and protect quality of life for breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.