Clinical trial NCT04714203: Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients
Official title: Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Lead sponsor: Weprom
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of sarcopenia
timeFrame: 1 month
Secondary outcomes:
measure: Prevalence of undernutrition
timeFrame: 1 month
measure: Overall survival
timeFrame: 6 months
measure: Progression free survival
timeFrame: 6 months
measure: Event free survival
timeFrame: 6 months
measure: Correlation between PRONOPALL score and sarcopenia
timeFrame: 1 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Clinique Victor Hugo / Centre Jean Bernard
Study officials:
affiliation: Clinique Victor Hugo/Centre Jean Bernard
name: Katell LE DU, MD
role: PRINCIPAL_INVESTIGATOR
References: