Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments (SARC-ONCO)

Centre Hospitalier Metropole Savoie

Status: Enrolling

Conditions: Physical Inactivity; Oncology; Sarcopenia; Toxicity Due to Chemotherapy

Treatments: Diagnostic Test: Sarcopenia diagnostic test

Study type: Interventional

Funder types: Other

Identifiers

NCT06274268

CHMS23006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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700 participants in 1 patient group

Interventionnal

Experimental group

Description:

"Hand Grip" Dynamometer Chair rise test measurement of impedance SEFI Nutritional Intake Assessment Questionnaire GPAQ questionnaire SARC-F questionnaire

Treatment:

Diagnostic Test: Sarcopenia diagnostic test