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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Hair Retention and Regrowth [Срок оценки: From enrollment to 12 weeks post-treatment with chemotherapy]
• Hair Retention and Chemotherapy-Induced Alopecia Distress [Срок оценки: From enrollment to 12 weeks post-treatment with chemotherapy]

Вторичные конечные точки (1)

• Role of Single Nucleotide Variations [Срок оценки: From enrollment to 12 weeks post-treatment with chemotherapy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ballad Health Cancer Care — Kingsport

Идентификаторы

NCT: NCT07422376 · 2025-149

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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