Clinical trial NCT06274268: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
Official title: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Oncology
Physical Inactivity
Toxicity Due to Chemotherapy
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
Collaborators: name: Université Savoie Mont Blanc
First posted: 2024-02-23
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Event-free survival according to sarcopenic statut
timeFrame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks
Secondary outcomes:
measure: 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.
timeFrame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks
measure: Progression free-survival
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Objective response rate at 6 and 12 months
timeFrame: 6 and 12 months
measure: Number of patients classified as sarcopenic by BIA method and CT method.
timeFrame: at baseline
measure: Exploratory: Event-free survival during PACLITAXEL protocol
timeFrame: 14 weeks after initiation of paclitaxel protocol
measure: Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2).
timeFrame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks.
measure: Exploratory: RCB-based objective response rate at 6 and 12 months
timeFrame: At the time of surgical mastectomy
Other outcomes:
Locations:
city: Chambéry
country: France
facility: Centre Hospitalier Metropole Savoie
Study officials:
affiliation: Centre Hospitalier Metropole Savoie
name: Aurelie FILLON
role: PRINCIPAL_INVESTIGATOR
References: