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

Last updated: July 18, 2024
Sponsor: University Hospital, Caen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Carcinoma

Sarcopenia

Treatment

sarcopenia and mobility measurement

Clinical Study ID

NCT03362801
SAMPHYR 16-181.
  • Ages > 65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Life expectancy <6 months

  • other active malignant tumors or other severe concomitant chronic pathologiesaffecting the general condition of the patient and / or likely to limitcompliance with the requirements of the study.

  • treatments incompatible with the study: previous corticosteroid treatmentprolonged for more than one month (induces iatrogenic sarcopenia).

Study Design

Total Participants: 69
Treatment Group(s): 1
Primary Treatment: sarcopenia and mobility measurement
Phase:
Study Start date:
October 30, 2017
Estimated Completion Date:
February 01, 2026

Connect with a study center

  • Caen University Hospital

    Caen,
    France

    Active - Recruiting

  • APHM

    Marseille,
    France

    Active - Recruiting

  • Rouen UH

    Rouen,
    France

    Suspended

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