Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
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
- В протоколе указаны: Sarcopenia diagnostic test.
- Кому может быть актуально
- Состояния в реестре: Sarcopenia, Oncology, Physical Inactivity, Toxicity Due to Chemotherapy. Базовые параметры: от 18 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study
Обзор
The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers. The main question it aims to answer is : Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment? The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests.
Подробное описание
The present study is single-center within the Centre Hospitalier Metropole Savoie, interventional and prospective, and will be carried out in patients suffering from cancer and having received an indication for systemic oncological treatment, in first line,
The inclusion visit (V1) will take place during the first chemotherapy session and will include study-specific measurements for the assessment of sarcopenia (impedancemetry, grip strength and chair rise test) as well as the distribution of actimeters to patients. The duration of these examinations carried out in addition to clinical practice is estimated at 15 minutes and does not involve any particular risks for patients.
Data collection 1 (R1) will be carried out during the second course of chemotherapy, data collection 2 (R2) will be carried out 6 months from the start of treatment, and data collection 3 (R3) at 12 months from the start of treatment. inclusion, based on standardized extraction of the medical file.
An exploratory study will be offered to patients treated in the context of adjuvant or neoadjuvant breast cancer and treated by the AC/PACLITAXEL protocol which will involve a second optional visit (optional V1.1) during the first injection of PACLITAXEL . An optional data collection (R1.1) will take place during the first cycle to collect actimetry data. And an optional data collection (R1.2) will take place 2 weeks after the theoretical end of PACLITAXEL in order to collect on file the grades of neuropathies and toxicities over the interval.
The visits will be carried out as part of the usual patient care.
Apart from the measurement of impedancemetry, grip strength, the chair rise test and actimetry, no other clinical, paraclinical intervention or biological analysis will be induced by the protocol.
Вмешательства
- Диагностический тест Sarcopenia diagnostic test
the study-specific measurements for the assessment of sarcopenia (impedancemetry, grip strength and chair rise test) as well as the distribution of actimeters to patients.
Первичные конечные точки
- Event-free survival according to sarcopenic statut [Срок оценки: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks]
Вторичные конечные точки (8)
- Event-free survival according to the link between: 1/ the dose/lean mass ratio and 2/ body composition and the occurrence of adverse events linked to treatment. [Срок оценки: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks]
- Progression free-survival [Срок оценки: 12 months]
- Overall survival [Срок оценки: 12 months]
- Objective response rate at 6 and 12 months [Срок оценки: 6 and 12 months]
- Number of patients classified as sarcopenic by BIA method and CT method. [Срок оценки: at baseline]
- Exploratory: Event-free survival during PACLITAXEL protocol [Срок оценки: 14 weeks after initiation of paclitaxel protocol]
- Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2). [Срок оценки: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks.]
- Exploratory: RCB-based objective response rate at 6 and 12 months [Срок оценки: At the time of surgical mastectomy]
Критерии участия
Критерии включения
- Patients over 18 years old
- Patient with a diagnosis of a histologically proven solid malignant tumor with an indication for systemic treatment during initial treatment.
- CT/PET performed within 45 days before initiation of systemic treatment.
- Patient able to sign informed consent for participation in the study
- Patient affiliated to a social security system
Критерии исключения
- History of cancer in the five years preceding inclusion other than localized skin or cervical cancers.
- Patient with cancer not requiring systemic treatment.
- Pregnant women.
- Patient with a pace maker or defibrillator
- Patient deprived of liberty or benefiting from a legal protection measure
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
- Диагностика
Центры проведения
Франция · 1 центр
- Centre Hospitalier Metropole Savoie — Chambéry
Идентификаторы
NCT: NCT06274268 · CHMS23006