Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients

NCT04714203 | Completed

• 1 other identifier: WP-2019-04
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Prevalence of undernutrition

  1 month

• Overall survival

  6 months

• Progression free survival

  6 months

• Event free survival

  6 months

• Correlation between PRONOPALL score and sarcopenia

  1 months

Study Arms (1)

cohort

Sarcopenia assessment

Other: sarcopenia assessment

Interventions

sarcopenia assessment OTHER

evaluation of sarcopenia status

cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weprom: lead

Study Sites (1)

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, 72000, France

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katell LE DU, MD

  Clinique Victor Hugo/Centre Jean Bernard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: June 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)