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

C

Caen University Hospital

Status

Enrolling

Conditions

Bladder Cancer
Sarcopenia

Treatments

Diagnostic Test: sarcopenia and mobility measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT03362801
SAMPHYR 16-181.

Details and patient eligibility

About

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

Enrollment

69 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

69 participants in 2 patient groups

Sarcopenic
Other group
Description:
sarcopenic status the day before cystectomy.
Treatment:
Diagnostic Test: sarcopenia and mobility measurement
not sarcopenic
Other group
Description:
sarcopenic status the day before cystectomy.
Treatment:
Diagnostic Test: sarcopenia and mobility measurement

Trial contacts and locations

3

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Central trial contact

helene legros; françois fournel

Data sourced from clinicaltrials.gov

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