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

Sponsor

University Hospital, Caen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03362801

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Bladder Cancer	Diagnostic Test: sarcopenia and mobility measurement	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

69 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 30, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Sarcopenic sarcopenic status the day before cystectomy.	Diagnostic Test: sarcopenia and mobility measurement walking speed, grip strength and BIA. QAPPA questionnaire (validated in French in the elderly) and the objective measurement of the time of activity and rest on a week per wrist actimeter. Comprehensive Geriatric Assessment
Other: not sarcopenic sarcopenic status the day before cystectomy.	Diagnostic Test: sarcopenia and mobility measurement walking speed, grip strength and BIA. QAPPA questionnaire (validated in French in the elderly) and the objective measurement of the time of activity and rest on a week per wrist actimeter. Comprehensive Geriatric Assessment

Arm

Intervention/Treatment

Other: Sarcopenic

sarcopenic status the day before cystectomy.

Diagnostic Test: sarcopenia and mobility measurement

walking speed, grip strength and BIA. QAPPA questionnaire (validated in French in the elderly) and the objective measurement of the time of activity and rest on a week per wrist actimeter. Comprehensive Geriatric Assessment

Other: not sarcopenic

sarcopenic status the day before cystectomy.

Diagnostic Test: sarcopenia and mobility measurement

Outcome Measures

Primary Outcome Measures

post-operative morbidity [at 30 days]
evaluated according to Clavien-Dindo classification
post-operative mortality [at 30 days]

Secondary Outcome Measures

post-operative complications [8 months]
Impact of dependancy (PS / ADL / IADL)
post-operative complications [8 months]
physical activity scores (QAPPA) Questionnaire d'activité physique pour les personnes âgées in French validated in French population - total score is used
post-operative complications [8 months]
physical performance (PBP)
post-operative complications [8 months]
fatigue (BFI) Brief Fatigue Inventory questionnaire
post-operative complications [8 months]
history of fall
post-operative complications [8 months]
pain (visual analogic scale for pain 0 to 10)
post-operative complications [8 months]
hours of mobility (actimetry)
post-operative complications [8 months]
hours of daily rest (actimetry) measured during 3 consecutives days
post-operative complications [8 months]
Actimetry
post-operative complications [8 months]
nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )
post-operative complications [8 months]
cognitive status (normal or not)
post-operative complications [8 months]
polymedication (≥5 / day)
post-operative complications [8 months]
comorbidities (updated charlson)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	Country
1	Caen University Hospital	Caen	France
2	APHM	Marseille	France
3	Rouen UH	Rouen	France

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT03362801

Other Study ID Numbers:

SAMPHYR 16-181.

First Posted:

Dec 5, 2017

Last Update Posted:

Sep 30, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Caen

physical activity

elderly

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Sarcopenia

Study Results

No Results Posted as of Sep 30, 2021