SarcopeniaSARC-ONCONCT06274268
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
A study testing Sarcopenia diagnostic test in people with Sarcopenia and Oncology, run by Centre Hospitalier Metropole Savoie at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Oncology, Physical Inactivity
- What is being tested?
- Sarcopenia diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jun 2024to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Metropole Savoie
Chambéry, 73000
aurelie fillon, 04.79.96.58.13, aurelie.fillon@ch-metropole-savoie.fr
florence jego, 04.79.96.58.13, florence.jego@ch-metropole-savoie.fr
About this study
Official title: Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study
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.
Read the 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.
- Being tested
- Sarcopenia diagnostic test
- Medical subject headings
- Sarcopenia, Neoplasms, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarcopenia diagnostic testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Interventionnal | Experimental | "Hand Grip" Dynamometer Chair rise test measurement of impedance SEFI Nutritional Intake Assessment Questionnaire GPAQ questionnaire SARC-F questionnaire Receives: Diagnostic Test: Sarcopenia diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 6 and 12 months
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.
Measured: at baseline
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.
Measured: 14 weeks after initiation of paclitaxel protocol
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.
Measured: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks.
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.
Measured: At the time of surgical mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start24 Jun 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Metropole Savoie
- Sponsor type
- University, hospital or other
- Collaborators
- Université Savoie Mont Blanc
- Responsible party
- Sponsor
- Investigators
- Aurelie FILLON, Principal investigator, Centre Hospitalier Metropole Savoie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274268
- Sponsor's protocol ID
- 2023-A02805-40
- Acronym
- SARC-ONCO
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments. Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06274268
- Acronym / sponsor ID
- SARC-ONCO / 2023-A02805-40
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Centre Hospitalier Metropole SavoieUniversity, hospital or other
- Collaborators
- Université Savoie Mont Blanc
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Interventionnal | Experimental | Diagnostic Test: Sarcopenia diagnostic test"Hand Grip" Dynamometer Chair rise test measurement of impedance SEFI Nutritional Intake Assessment Questionnaire GPAQ questionnaire SARC-F questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarcopenia 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. | Diagnostic test | Interventionnal |
Primary outcome
Event-free survival according to sarcopenic statut
Time frame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks
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.
8 secondary outcomes
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.
Time frame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks
Progression free-survival
Time frame: 12 months
Overall survival
Time frame: 12 months
Objective response rate at 6 and 12 months
Time frame: 6 and 12 months
Number of patients classified as sarcopenic by BIA method and CT method.
Time frame: at baseline
Exploratory: Event-free survival during PACLITAXEL protocol
Time frame: 14 weeks after initiation of paclitaxel protocol
Exploratory: Level of spontaneous activity measurement by accelerometry (m.s-2).
Time frame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks.
Exploratory: RCB-based objective response rate at 6 and 12 months
Time frame: At the time of surgical mastectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurelie FILLON principal investigator
Centre Hospitalier Metropole Savoie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sarcopenia diagnostic test in people with Sarcopenia and Oncology, run by Centre Hospitalier Metropole Savoie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurelie FILLON (04.79.96.58.13, aurelie.fillon@ch-metropole-savoie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-free survival according to sarcopenic statut (time frame: Day 1 of the first treatment cycle to Day 1 of the second treatment cycle, approx. 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.