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

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

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on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).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

Study Overview

• Status: Not yet recruiting
• Conditions: Leukemia, Myeloid, Acute; Metastatic Cancer; Cancer, Rectum; Myelodysplasia; Cancer, Breast; Myeloma; Leukemia, Lymphocytic, Acute; Cancer, Lung; Cancer Colon; Leukemia, Lymphocytic, Chronic; Cancer, Kidney; Cancer Pancreas; Cancer Prostate; Leukemia,Myeloid, Chronic; Cancer Ovaries
• Intervention / Treatment: Other: Standard

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Katell Le Dû, MD
• Study Contact Backup: Name: Magali BALAVOINE; Phone Number: +33(0)241682940; Email: m.balavoine@ilcgroupe.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Clinique Victor Hugo/Centre Jean Bernard
    • Contact: Julien DOMONT, MD
    • Principal Investigator: Julien DOMONT, MD
  • Nantes, France, 44000
    • Clinique privé du Confluent
    • Principal Investigator: Katell Le Dû, MD
    • Contact: Katell Le Dû, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients will be recruited during medical consultations or hospitalization in an onco-hematology service

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of patients with sarcopenia diagnosed with metastatic cancer.	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..	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	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.	18 months
Event Free survival	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)	18 months
Progression Free survival	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	18 months
Unanticipated hospitalization rate	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	18 months
Statistical relationship between sarcopenia and the PRONOPALL score	For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)	18 months
Rate of undernourished patients	Calculated according to WHO classification	18 months
Rate of patients with sarcopenia at diagnosis across the inclusive population	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	18 months

Collaborators and Investigators

• Sponsor: Weprom
• Investigators: Principal Investigator: Katell LE DU, MD, Private Hospital of Confuent, Nantes

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: nutrition; sarcopenia; quality of life questionnaire
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lung Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Bone Marrow Diseases; Hematologic Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Myeloproliferative Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Intestinal Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Muscular Atrophy; Atrophy; Leukemia, B-Cell; Neoplasms; Kidney Neoplasms; Breast Neoplasms; Hematologic Neoplasms; Lung Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasm Metastasis; Rectal Neoplasms; Sarcopenia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Neoplasms, Second Primary
• Other Study ID Numbers: WP-2021-03; 2021-A01670-41 (Other Identifier: French Health Products Safety Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No