Clinical trial NCT05154474: Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy
Official title: Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Cancer
Cancer, Breast
Cancer Colon
Cancer, Rectum
Cancer, Lung
Cancer Ovaries
Cancer Prostate
Cancer, Kidney
Cancer Pancreas
Myeloma
Myelodysplasia
Leukemia, Myeloid, Acute
Leukemia,Myeloid, Chronic
Leukemia, Lymphocytic, Acute
Leukemia, Lymphocytic, Chronic
Keywords: sarcopenia
quality of life questionnaire
nutrition
Lead sponsor: Weprom
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited during medical consultations or hospitalization in an onco-hematology service

Brief summary: Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).

A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.


Eligibility criteria: Inclusion Criteria:

1. Patient aged 18 years or older
2. Patient with solid cancer diagnosed with metastatic disease,or hematological disease requiring treatment (myeloma, lymphoma, high-risk myelodysplasia, acute or chronic myeloid leukemia, acute and chronic lymphoid leukemia)
3. Patient naive of cancer treatment
4. Pathology including performing a CT scan with cuts of the lumbar spine in standard care
5. Patient enrolled in social security
6. Patient has given his written consent ahead of any specific protocol procedure.

Exclusion Criteria:

1. Minor patient
2. Metastatic neurological impairment
3. Patient deprived of their liberty, under guardianship or trusteeship
4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
6. Patient is pregnant
7. History of cancer treated (excluding surgery alone for tumors in situ) within 5 years of inclusion

Primary outcomes:
measure: Rate of patients with sarcopenia diagnosed with metastatic cancer.
timeFrame: At inclusion
Secondary outcomes:
measure: Overall Survival
timeFrame: 18 months
measure: Event Free survival
timeFrame: 18 months
measure: Progression Free survival
timeFrame: 18 months
measure: Unanticipated hospitalization rate
timeFrame: 18 months
measure: Statistical relationship between sarcopenia and the PRONOPALL score
timeFrame: 18 months
measure: Rate of undernourished patients
timeFrame: 18 months
measure: Rate of patients with sarcopenia at diagnosis across the inclusive population
timeFrame: 18 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Clinique Victor Hugo/Centre Jean Bernard
city: Nantes
country: France
facility: Clinique privé du Confluent
Study officials:
affiliation: Private Hospital of Confuent, Nantes
name: Katell LE DU, MD
role: PRINCIPAL_INVESTIGATOR
References: