Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT06274268
Status:
RECRUITING
Last Update Posted:
2024-07-18
First Post:
2024-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
Sponsor:
Centre Hospitalier Metropole Savoie
Organization:
Study Overview
Official Title:
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SARC-ONCO
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: