Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients (SPACE)

Cancer is one of the leading causes of death in the world after cardiovascular disease (8.7 million deaths in 2015 for 17.5 million cases) 1. Despite a great deal of progress in disease detection and treatment, the incidence of cancer is steadily increasing (+ 33% in 2015) and particularly in certain locations (pancreas, lungs, brain and stomach), including risk factors are not always identified.

Advanced stage cancer (= metastatic) is most often incurable with the exception of germ cell tumors. Palliative care is then most often offered. Palliative care favors the patient's quality of life as a whole (medical, physical, psychological and social).

The symptoms most often reported by patients are: pain, fatigue, decreased appetite, nausea, and are directly related to phenomena such as cachexia, loss of autonomy and deterioration of psychological state, resulting in decreased overall survival. Chemotherapies and targeted therapies (immunotherapy, hormonal therapy, participation in a clinical trial) can provide a benefit in quality of life and survival only in the early phase (little benefit in the terminal phase).

Other prognostic factors can impact the quality of life and overall survival in these situations: sarcopenia and disorders of nutritional status (obesity, undernutrition).

The study of sarcopenia by CT scan of patients in a palliative situation is still too scarce. Sarcopenia is an often underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality.

The study of the prevalence of sarcopenia by CT scan would confirm its prognostic impact in a palliative situation.

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer
• Intervention / Treatment: Other: sarcopenia assessment

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72000
    • Clinique Victor Hugo / Centre Jean Bernard

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: Non-Probability Sample

Study Population

The population will include all patients diagnosed with metastatic disease (either present at diagnosis or occurring after an initially localized cancer).

Description

Inclusion Criteria:

• age> 18 years old,
• patient with solid cancer diagnosed with metastatic disease,
• having had a biological assessment and a CT scan in the month preceding the medical consultation,
• and whose prognosis is considered palliative

Exclusion Criteria:

• age <18 years old,
• adults under guardianship measure,
• pregnancy or breastfeeding in progress,
• malignant hemopathies,
• metastatic germ cell tumors,
• non-metastatic disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cohort; Sarcopenia assessment	Other: sarcopenia assessment; evaluation of sarcopenia status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of sarcopenia	Number of patients with sarcopenia in the numerator out of the total number of patients included in the study in the denominator	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of undernutrition	Number of patients with nutritional disorders at inclusion in numerator out of the number of patients followed in denominator	1 month
Overall survival	Time between the inclusion date and the date of death regardless of the cause or the date of the latest news if the patient is censored	6 months
Progression free survival	Time between the inclusion date and the date of the first examination showing Time disease progression or the date of death if the patient is deceased or the date of the latest news if the patient is censored	6 months
Event free survival	Time between the date of inclusion and the date of the first event identified or the date of death if the patient is deceased or the date of the latest news if the patient is censored	6 months
Correlation between PRONOPALL score and sarcopenia	Calculation of PRONOPALL score (high score corresponds to a worse situation)	1 months

Collaborators and Investigators

• Sponsor: Weprom

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 31, 2019

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (ACTUAL): January 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: WP-2019-04

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