Mepitel Film Breast
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Radiation Dermatitis. Базовые параметры: 21 лет — 100 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Сингапур
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
The Tolerability of Mepitel Film for the Prevention of Radiation Dermatitis in Breast Cancer Patients in Hot Weather: A Feasibility Study
Обзор
Primary Objective To examine the tolerability of Mepitel Film in the prevention of RD patients undergoing whole breast or chest wall RT in the hot and humid weather in Singapore Secondary Objectives To evaluate the incidence of acute radiation dermatitis, quality of life, satisfaction, and cost analysis of Mepitel Film use.
Подробное описание
This prospective, observational feasibility study will enroll 60 breast cancer patients, divided into two cohorts: 30 receiving local breast RT and 30 receiving chest wall RT post-mastectomy. We hypothesize that Mepitel Film will be well-tolerated and effective in preventing severe RD (Grade ≥2) in this population, with results compared to published data from Western countries. Previous randomized controlled trials (RCTs) conducted in regions with low humidity and cool temperatures have raised concerns about film adherence and cost in tropical climates. Therefore, assessing the efficacy of Mepitel Film in a hot and humid environment is warranted.
Первичные конечные точки
- Frequency of total replacement of Mepitel Film or "touch-up" when compared with the data from the RCT in Ontario, Canada [Срок оценки: From first day RT to the 2 weeks post RT]
Вторичные конечные точки (12)
- Frequency and severity of patient reported pruritis in SSA and RISRAS related to use of Mepitel Film when compared with the data from the RCT in Ontario, Canada [Срок оценки: From enrollment to the 3 months post RT]
- Incidence of ARD grades 2 to 3, as defined by the CTCAE V5 assessed by HCP [Срок оценки: From enrollment to the 2 weeks post RT]
- Patient-reported skin-related symptoms using the Skin Symptom Assessment (SSA) [Срок оценки: From enrollment to the end of study (2 years post RT)]
- HCP reported SSA [Срок оценки: From enrollment to the end of study (2 years post RT)]
- Incidence of moist desquamation assessed by HCP [Срок оценки: From enrollment to 2 weeks post RT]
- Radiation-Induced Skin Reaction Assessment Scale (RISRAS) assessed by patient and HCP [Срок оценки: From enrollment to 3 months post RT]
- Blinded HCP-assessed mRISRAS scores from blinded grading of photographs taken at the end of RT [Срок оценки: End of RT treatment]
- Photographs with EORTC-BCRS [Срок оценки: From enrollment to the end of study (2 years post RT)]
- Patient-reported QOL using the Skindex-16 [Срок оценки: From enrollment to the end of study (2 years post RT)]
- Patient satisfaction with Mepitel Film as assessed by the patient satisfaction questionnaire [Срок оценки: 3 months post RT]
- HCP satisfaction with Mepitel Film as assessed by the HCP satisfaction questionnaire [Срок оценки: 3 months post RT]
- Cost analysis of Mepitel Film for prevention of RD (evaluation and calculation of Mepitel Film usage and financial cost using Film Integrity Assessment) [Срок оценки: From first day RT to the 2 weeks post RT]
Критерии участия
Критерии включения
- Age ≥ 21 years old (legal age of maturity in Singapore)
- Male or female
- Informed consent
- Patients have undergone a mastectomy with or without reconstruction or breast-conserving surgery.
- Histological confirmation of breast carcinoma (invasive or in situ carcinoma)
- Patients are scheduled to receive hypofractionated (40Gy in 15 daily fractions or 26Gy in 5 daily fractions) photon-based RT
- Patient treated with or without tissue the addition of equivalent bolus and/or boost.
- Can communicate in English or be aided by a translator.
Критерии исключения
- Prior RT to any portion of the planned treatment site.
- Patients will receive partial breast external beam RT, proton beam therapy, or brachytherapy.
- Patients with active rash, pre-existing dermatitis, or other conditions within the treatment area may make skin assessment for the study difficult per treating physician discretion.
- Known history of adhesive, tape or silicon allergy or sensitivity.
- Concomitant cytotoxic chemotherapy
- Bilateral breast pathology requiring concurrent bilateral breast or chest wall RT.
- Current inflammatory breast cancer or gross dermal involvement at initiation of RT.
- Patient has a Karnofsky Performance Status score <60.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Сингапур · 1 центр
- National University Hospital — Singapore
Идентификаторы
NCT: NCT07729423 · 2024-4228