Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Metropole Savoie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sarcopenia diagnostic test
Diagnostic testthe study-specific measurements for the assessment of sarcopenia (impedancemetry, grip strength and chair rise test) as well as the distribution of actimeters to patients.
Treatment groups
700 Participants
are divided into 1 treatment groupGroup A: InterventionnalExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeksSecondary outcomes
1
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.
Event-free survival will be defined as for the primary outcome. The measure will be analyzed using a COX multivariate model with event incidence rate as dependant variable and the sarcopenia statut, the dose/lean mass ratio and the body composition indices (fat free mass (kg) and fat mass (kg)), as independent variables.
Time frame
Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks2
Progression free-survival
Progression : ≥ 20% increase in the sum of the diameters of the target lesions compared to the smallest sum of the diameters observed during the study (NADIR), including the baseline visit. In addition to this relative increase of 20%, this sum must increase by at least 0.5 cm. Note: the appearance of one or more new lesions is also considered progression. Progression-free survival will be defined as the time from the date of the experimental visit to the date of the first documented progression. Participants who will not experience a progression as of the time of data cut-off (end of 12 month follow-up) 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 progression incidence rate as dependant variable and the sarcopenia statut, the dose/lean mass ratio and the body composition indices (fat free mass (kg) and fat mass (kg)), as independent variables.
Time frame
12 months3
Overall survival
Overall survival will be defined as the time from the date of the experimental visit to the date of death (irrespective of cause). Participants who will be alive at the time of data cut-off (end of 12 month follow-up) 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 death incidence rate as dependant variable and the sarcopenia statut, the dose/lean mass ratio and the body composition indices (fat free mass (kg) and fat mass (kg)), as independent variables.
Time frame
12 months4
Objective response rate at 6 and 12 months
For metastatic or locally advanced patients, ORR will be defined as the percentage of subjects with Complete response (CR) or Partial response (PR), according to RECIST v1.1. For patients in adjuvant/neoadjuvant treatment, ORR will be defined as the percentage of subjects with confirmation of no relapse by the investigator based on the analysis of an imaging examination. ORR will be analyze as dependent variable in a logistic regression model including sarcopenia statut, the dose/lean mass ratio and the body composition indices (fat free mass (kg) and fat mass (kg)) as independent variables.
Time frame
6 and 12 monthsSponsors and contacts
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Centre Hospitalier Metropole Savoie
Lead sponsor
Université Savoie Mont Blanc
Collaborator
Source ClinicalTrials.gov