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

Metastatic Cancer Clinical Trial

— SPACE2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05154474
• Other study ID #: WP-2021-03
• Secondary ID: 2021-A01670-41
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2021
• Source: Weprom
• Contact: Magali BALAVOINE
• Phone: +33(0)241682940
• Email: m.balavoine[@]ilcgroupe.fr
• Is FDA regulated: No
• Study type: Observational

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on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: August 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer Colon
• Cancer Ovaries
• Cancer Pancreas
• Cancer Prostate
• Cancer, Breast
• Cancer, Kidney
• Cancer, Lung
• Cancer, Rectum
• Hematologic Neoplasms
• Kidney Neoplasms
• Leukemia
• Leukemia, Lymphocytic, Acute
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia,Myeloid, Chronic
• Lung Neoplasms
• Metastatic Cancer
• Myelodysplasia
• Myeloma
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Rectal Neoplasms
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
France	Clinique Victor Hugo/Centre Jean Bernard	Le Mans
France	Clinique privé du Confluent	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Weprom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Statistical relationship between sarcopenia and the PRONOPALL score	For the cancer subtypes concerned (breast, colon, rectum, lungs, ovaries, prostate, kidney, pancreas)	18 months
Secondary	Rate of undernourished patients	Calculated according to WHO classification	18 months
Secondary	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