NCT03362801

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

July 19, 2024

Status Verified

September 1, 2023

Enrollment Period

7.7 years

First QC Date

March 7, 2017

Last Update Submit

July 18, 2024

Conditions

SarcopeniaBladder Cancer

Keywords

physical activityelderly

Outcome Measures

Primary Outcomes (2)

  • post-operative morbidity

    evaluated according to Clavien-Dindo classification

    at 30 days

  • post-operative mortality

    at 30 days

Secondary Outcomes (17)

  • post-operative complications

    8 months

  • post-operative complications

    8 months

  • post-operative complications

    8 months

  • post-operative complications

    8 months

  • post-operative complications

    8 months

  • +12 more secondary outcomes

Study Arms (2)

Sarcopenic

OTHER

sarcopenic status the day before cystectomy.

Diagnostic Test: sarcopenia and mobility measurement

not sarcopenic

OTHER

sarcopenic status the day before cystectomy.

Diagnostic Test: sarcopenia and mobility measurement

Interventions

sarcopenia and mobility measurementDIAGNOSTIC_TEST

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

Sarcopenicnot sarcopenic

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Caen University Hospital

Caen, France

RECRUITING

APHM

Marseille, France

RECRUITING

Rouen UH

Rouen, France

SUSPENDED

Related Publications (5)

  • Audisio RA, Bozzetti F, Gennari R, Jaklitsch MT, Koperna T, Longo WE, Wiggers T, Zbar AP. The surgical management of elderly cancer patients; recommendations of the SIOG surgical task force. Eur J Cancer. 2004 May;40(7):926-38. doi: 10.1016/j.ejca.2004.01.016.

    PMID: 15093567RESULT

  • Huisman MG, van Leeuwen BL, Ugolini G, Montroni I, Spiliotis J, Stabilini C, de'Liguori Carino N, Farinella E, de Bock GH, Audisio RA. "Timed Up & Go": a screening tool for predicting 30-day morbidity in onco-geriatric surgical patients? A multicenter cohort study. PLoS One. 2014 Jan 24;9(1):e86863. doi: 10.1371/journal.pone.0086863. eCollection 2014.

    PMID: 24475186RESULT

  • Shachar SS, Williams GR, Muss HB, Nishijima TF. Prognostic value of sarcopenia in adults with solid tumours: A meta-analysis and systematic review. Eur J Cancer. 2016 Apr;57:58-67. doi: 10.1016/j.ejca.2015.12.030. Epub 2016 Feb 13.

    PMID: 26882087RESULT

  • Psutka SP, Carrasco A, Schmit GD, Moynagh MR, Boorjian SA, Frank I, Stewart SB, Thapa P, Tarrell RF, Cheville JC, Tollefson MK. Sarcopenia in patients with bladder cancer undergoing radical cystectomy: impact on cancer-specific and all-cause mortality. Cancer. 2014 Sep 15;120(18):2910-8. doi: 10.1002/cncr.28798. Epub 2014 May 19.

    PMID: 24840856RESULT

  • Smith AB, Deal AM, Yu H, Boyd B, Matthews J, Wallen EM, Pruthi RS, Woods ME, Muss H, Nielsen ME. Sarcopenia as a predictor of complications and survival following radical cystectomy. J Urol. 2014 Jun;191(6):1714-20. doi: 10.1016/j.juro.2013.12.047. Epub 2014 Jan 11.

    PMID: 24423437RESULT

MeSH Terms

Conditions

SarcopeniaUrinary Bladder NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesBehavior

Central Study Contacts

françois fournel

CONTACT

+33231065488fournel-f@chu-caen.fr

helene legros

CONTACT

legros-h@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2017

First Posted

December 5, 2017

Study Start

October 30, 2017

Primary Completion

July 1, 2025

Study Completion

February 1, 2026

Last Updated

July 19, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)