NCT06274268

Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments

Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Centre Hospitalier Metropole Savoie · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sarcopenia
• Oncology
• Physical Inactivity
• Toxicity Due to Chemotherapy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-24
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2024-02-23
• Last updated: 2024-07-18

Locations

1 site across 1 country: France