Informations générales (source: ClinicalTrials.gov)
SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly (SAMPHYR)
Interventional
N/A
University Hospital, Caen (Voir sur ClinicalTrials)
octobre 2017
février 2026
20 juillet 2024
Sarcopenia is associated with lower prognosis in solid tumors, but this has not been
studied in bladder carcinoma requiring cystectomy.
According to EWGSOP recommendations, the diagnosis of sarcopenia is based on walking
speed, grip strength and muscle mass. These three elements can easily be measured
(specially muscle mass measurement by bioimpedencemetry or tomodensitometry).
This cohort study will collect clinical complementary elements to better understand the
associated factors present with sarcopenia, in order to prepare an interventional
preoperative physical reconditioning study.
The mobility measurement will be carried out by the QAPPA questionnaire (validated in
French in the elderly) and the quantitative measurement of activity and rest hours during
a week by a wrist actimeter.
Standardized geriatric data will also be collected: ADL, IADL for autonomy, MMSE for
cognitive status, nutritional status (% weight loss, BMI), pain, GDS15 for depression
screening, updated Charlson Comorbidity Index to identify polypathology and The STOPP
tool for potentially inappropriate medication.
Post-operative morbidity mortality at 30 days will be evaluated according to
Clavien-Dindo classification. Investigators will also evaluate 6 months geriatric
complications : falls, loss of autonomy and decreased mobility and physical activity,
cognitive degradation, undernutrition, institutionalization
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| APHM - Marseille - France | Emilie Nouzergues | Contact (sur clinicalTrials) | |||
| Caen University Hospital - Caen - France | Bérengère Beauplet, PhD | Contact (sur clinicalTrials) | |||
| Rouen UH - Rouen - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- confirmed urothelial bladder carcinoma ( RTUV)
- indication of radical cystectomy
- Able, informed and with informed consent for the study
- affiliated to the social security system
- talking French
- confirmed urothelial bladder carcinoma ( RTUV)
- indication of radical cystectomy
- Able, informed and with informed consent for the study
- affiliated to the social security system
- talking French
- Life expectancy <6 months
- other active malignant tumors or other severe concomitant chronic pathologies
affecting the general condition of the patient and / or likely to limit
compliance with the requirements of the study.
- treatments incompatible with the study: previous corticosteroid treatment
prolonged for more than one month (induces iatrogenic sarcopenia).