Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- Event-free survival according to sarcopenic statut
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Event-free survival according to sarcopenic statut
时间窗: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks
Event-free survival will be defined as the time from the date of the experimental visit to the date of the first documented dose-limiting toxicity. Participants who will not experience an event as of the time of data cut-off (beginning of the second cycle of treatment) or who stopped study participation before the end of the follow-up, will be right-censored. The measure will be analyzed using a COX multivariate model with event incidence rate as dependant variable and the sarcopenia statut as independent variable.
次要结局
- 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.(Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks)
- Exploratory: Event-free survival during PACLITAXEL protocol(14 weeks after initiation of paclitaxel protocol)
- Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2).(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(At the time of surgical mastectomy)
- Overall survival(12 months)
- Objective response rate at 6 and 12 months(6 and 12 months)
- Number of patients classified as sarcopenic by BIA method and CT method.(at baseline)
- Progression free-survival(12 months)