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

Sarcopenia Clinical Trial

— SARC-ONCO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06274268
• Other study ID #: CHMS23006
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Metropole Savoie
• Contact: Aurelie FILLON
• Phone: 04.79.96.58.13
• Email: aurelie.fillon[@]ch-metropole-savoie.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Metropole Savoie	Université Savoie Mont Blanc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	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.	6 and 12 months
Secondary	Number of patients classified as sarcopenic by BIA method and CT method.	Taking CT evaluation as the reference method, evaluate: the sensitivity, specificity, negative and positive predictive value of BIA to detect sarcopenia.	at baseline
Secondary	Exploratory: Event-free survival during PACLITAXEL protocol	Event-free survival will be defined as the time from the date of the first PACLITAXEL injection 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 (14 weeks after the initiation of PACLITAXEL protocol) 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 dependent variable and the sarcopenia statut as independent variables.	14 weeks after initiation of paclitaxel protocol
Secondary	Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2).	Compare, according to sarcopenic status and the occurrence of treatment-related adverse events, the level of spontaneous physical activity by accelerometry over the treatment 1/treatment 2 interval.	Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks.
Secondary	Exploratory: RCB-based objective response rate at 6 and 12 months	For patients with triple negative or HER2 positive breast tumor, ORR will be defined as the percentage of subjects with RCB (residual cancer burden) 0, I or II according to histological analysis of the surgical specimen. 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.	At the time of surgical mastectomy