Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

Официальное название

A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.

Обзор

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

Подробное описание

This is a prospectively enrolling, post-market, on-label study to assess the ability of the AMMA PSCS to prevent hair loss in women receiving CT for early-stage breast cancer, and to assess the safety, tolerability and compliance, patient quality of life, and satisfaction with hair after treatment. Female patients at least 21 years of age with stage I, II, or III breast cancer who are receiving a taxane-containing CT regimen that is scheduled to be completed within six months will be identified and data from the electronic health record (EHR) as well as prospective data will be collected.

AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy treatment.

Вмешательства

• Устройство AMMA Portalbe Scalp Cooling System
  AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

Первичные конечные точки

• Hair Loss [Срок оценки: 3 Weeks]

Вторичные конечные точки (8)

• Device-related adverse events [Срок оценки: 3 Weeks]
• Scalp changes [Срок оценки: 3 Weeks]
• Patient symptoms [Срок оценки: 3 Weeks]
• Subject's tolerability [Срок оценки: 3 Weeks]
• Patient assessment of hair loss [Срок оценки: 3 Weeks]
• Patient satisfaction and QoL - Body Image Scale (BIS) [Срок оценки: 3 Weeks]
• Patient satisfaction and QoL - European Organization for Research and Treatment (EORTC) QLQ-BR23 [Срок оценки: 3 Weeks]
• Device success [Срок оценки: 3 Weeks]

Критерии участия

Критерии включения

• Female patients ≥ 21 years of age
• Documented diagnosis of breast cancer, stage I, II, or III
• A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
• Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and/or hormonal therapy period
• Plan to complete the current CT regimen within six months
• At least two years out from the last CT causing hair loss with complete recovery of hair
• Karnofsky17 performance status 80% or greater
• Willing and able to sign informed consent for this study
• Willing and able to complete all required study procedures

Критерии исключения

• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
• Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others
• A history of whole brain radiation
• Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC/T, EC/T, TAC, etc.)
• Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
• Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique
• A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
• History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
• History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss
• Cold sensitivity
• Intercurrent life-threatening malignancy
• Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism
• History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
• Concurrent hematologic malignancy
• Participation in any other clinical investigation
• Concurrent treatment with any investigational agent
• Any reason the investigator does not believe the patient is a good candidate for the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• University of Arizona — Tucson
• Carle Health — Urbana

Идентификаторы

NCT: NCT05484973 · COOL-CLIN-2022-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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