Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients

Metastatic Cancer Clinical Trial

— SPACE  

Official title:

Assessment of the Prevalence of Sarcopenia in Early Palliative Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714203
• Other study ID #: WP-2019-04
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2021
• Source: Weprom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Sarcopenia

Intervention

Other:
• sarcopenia assessment
evaluation of sarcopenia status

Locations

Country	Name	City	State
France	Clinique Victor Hugo / Centre Jean Bernard	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Weprom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of undernutrition	Number of patients with nutritional disorders at inclusion in numerator out of the number of patients followed in denominator	1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlation between PRONOPALL score and sarcopenia	Calculation of PRONOPALL score (high score corresponds to a worse situation)	1 months