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NCT Number: NCT06274268

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

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.

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Key information

Conditions

Sarcopenia Atrophy Behavior Muscular Atrophy Neoplasms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Oncology Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Inactivity Sedentary Behavior Signs and Symptoms Toxicity Due to Chemotherapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sarcopenia diagnostic test

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.

Primary outcomes

  1. 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.

Secondary 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.

    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 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.

  2. Progression free-survival

    Time frame: 12 months

    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.

  3. Overall survival

    Time frame: 12 months

    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.

  4. Objective response rate at 6 and 12 months

    Time frame: 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.

  5. Number of patients classified as sarcopenic by BIA method and CT method.

    Time frame: at baseline

    Taking CT evaluation as the reference method, evaluate: the sensitivity, specificity, negative and positive predictive value of BIA to detect sarcopenia.

  6. Exploratory: Event-free survival during PACLITAXEL protocol

    Time frame: 14 weeks after initiation of 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.

  7. 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.

    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.

  8. Exploratory: RCB-based objective response rate at 6 and 12 months

    Time frame: At the time of surgical mastectomy

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurelie FILLON

CONTACT

[email protected]

04.79.96.58.13

Nathalie MARQUES, Dr

CONTACT

[email protected]

04.79.96.58.13

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Metropole Savoie

Other

Collaborators

  • Université Savoie Mont Blanc

Registry information

Official study title

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

Acronym: SARC-ONCO

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 23, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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