Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sarcopenia diagnostic test.
- Who it may be relevant to
- Registry conditions: Sarcopenia, Oncology, Physical Inactivity, Toxicity Due to Chemotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test 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.
Primary outcome measures
- Event-free survival according to sarcopenic statut [Time frame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks]
Secondary outcome measures (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. [Time frame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks]
- Progression free-survival [Time frame: 12 months]
- Overall survival [Time frame: 12 months]
- Objective response rate at 6 and 12 months [Time frame: 6 and 12 months]
- Number of patients classified as sarcopenic by BIA method and CT method. [Time frame: at baseline]
- Exploratory: Event-free survival during PACLITAXEL protocol [Time frame: 14 weeks after initiation of paclitaxel protocol]
- Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2). [Time frame: 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 [Time frame: At the time of surgical mastectomy]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Hospitalier Metropole Savoie — Chambéry
Identifiers
NCT: NCT06274268 · CHMS23006