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

NCT06274268 | Recruiting

• 1 other identifier: CHMS23006
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcopenia; Oncology; Physical Inactivity; Toxicity Due to Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Event-free survival according to sarcopenic statut

  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.

  Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks

Secondary Outcomes (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.

  Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks

• Progression free-survival

  12 months

• 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

Study Arms (1)

Interventionnal

EXPERIMENTAL

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

Diagnostic Test: Sarcopenia diagnostic test

Interventions

Sarcopenia diagnostic test 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.

Interventionnal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Metropole Savoie: lead
• Université Savoie Mont Blanc: collaborator

Study Sites (1)

Centre Hospitalier Metropole Savoie

Chambéry, 73000, France

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Neoplasms; Sedentary Behavior

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Aurelie FILLON

  Centre Hospitalier Metropole Savoie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurelie FILLON

CONTACT

04.79.96.58.13; aurelie.fillon@ch-metropole-savoie.fr

Nathalie MARQUES, Dr

CONTACT

04.79.96.58.13; nathalie.marques@ch-metropole-savoie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 23, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)