SPACE2: Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

Sponsor

Weprom (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05154474

Collaborator

(none)

150

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Standard

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assessment of the Proportion of Patients With Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy.

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Standard Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire	Other: Standard Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires

Arm

Intervention/Treatment

Standard

Standard follow-up MNA, IPAQ, SARC-F and SarQOL questionnaire

Other: Standard

Standard follow-up with clinical exams, functionnal test at baseline, Ct scan MNA, IPAQ, SARC-F and SarQOL questionnaires

Outcome Measures

Primary Outcome Measures

Rate of patients with sarcopenia diagnosed with metastatic cancer. [At inclusion]
Sarcopenia is defined for those under 60 years of age by LMSI<43.1 cm²/m² for men and <32.7 cm²/m² for women, and for patients over 60 years of age by <38.6 cm²/m² for men and <30.7 cm²/m² for women..

Secondary Outcome Measures

Overall Survival [18 months]
Calculated from the date of inclusion to the date of death due to any cause or the date last known to be alive if patient is censored.
Event Free survival [18 months]
Calculated from the date of start of treatment to the date of first event (progression, death, infectious complications, thrombosis, side effects of treatments of grade 2 or higher)
Progression Free survival [18 months]
Calculated from the date of start of treatment to the date of first progression of disease based on Investigator assessment or the date of death or censored at the date of the last valid tumor assessment before start of a new therapy for patients who are still alive and without progression
Unanticipated hospitalization rate [18 months]
Calculated from the date of start of treatment for all unplanned hospitalizations for side effects of treatments of grade 2 or higher, infectious complications, thrombosis, relapse or progression
Statistical relationship between sarcopenia and the PRONOPALL score [18 months]
For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)
Rate of undernourished patients [18 months]
Calculated according to WHO classification
Rate of patients with sarcopenia at diagnosis across the inclusive population [18 months]
Calculated from the number of patients who were screened for sarcopenia at diagnosis in the active file of patients meeting the inclusion criteria in all participating centers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient aged 18 years or older
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)
Patient naive of cancer treatment
Pathology including performing a CT scan with cuts of the lumbar spine in standard care
Patient enrolled in social security
Patient has given his written consent ahead of any specific protocol procedure.

Exclusion Criteria:

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