SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly

Not Applicable

Recruiting

• Conditions: Sarcopenia; Bladder Cancer
• Interventions: Diagnostic Test: sarcopenia and mobility measurement

• Registration Number: NCT03362801
• Lead Sponsor: University Hospital, Caen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-07
• Study Start: 2017-10-30
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Status Verified: 2023-09
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-07-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 69

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

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sarcopenic	sarcopenia and mobility measurement	sarcopenic status the day before cystectomy.
not sarcopenic	sarcopenia and mobility measurement	sarcopenic status the day before cystectomy.

Primary Outcome Measures

Name	Time	Method
post-operative morbidity	at 30 days	evaluated according to Clavien-Dindo classification
post-operative mortality	at 30 days

Secondary Outcome Measures

Name	Time	Method
post-operative complications	8 months	inappropriate prescriptions (STOPP)
impedancemetric value	2 months	Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value
sarcopenic status	between baseline; preoperative and at 6 months post-operative	evolution of sarcopenic status
quality of life scores	preoperative and 6-month post-operative	EORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items)

Trial Locations

Locations (3)

Caen University Hospital; 🇫🇷 Caen, France

Rouen UH; 🇫🇷 Rouen, France

APHM; 🇫🇷 Marseille, France