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

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

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; Bladder Cancer
• Intervention / Treatment: Diagnostic test: sarcopenia and mobility measurement

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: helene legros; Email: legros-h@chu-caen.fr
• Study Contact Backup: Name: françois fournel; Phone Number: +33231065488; Email: fournel-f@chu-caen.fr

Study Locations

• France
  • Caen, France
    • Recruiting
    • CAEN University Hospital
    • Contact: Bérengère Beauplet, PhD; Email: beauplet-b@chu-caen.fr
  • Marseille, France
    • Not yet recruiting
    • APHM
    • Contact: Emilie Nouzergues; Email: Emilie.NOUGUEREDE@ap-hm.fr
    • Principal Investigator: Anne-Laure Couderc, MD
  • Rouen, France
    • Recruiting
    • Rouen UH
    • Contact: Maeva Bizon; Email: Maeva.Bizon@chu-rouen.fr
    • Principal Investigator: Christian Pfister

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative morbidity	evaluated according to Clavien-Dindo classification	at 30 days
post-operative mortality		at 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative complications	Impact of dependancy (PS / ADL / IADL)	8 months
post-operative complications	physical activity scores (QAPPA) Questionnaire d'activité physique pour les personnes âgées in French validated in French population - total score is used	8 months
post-operative complications	physical performance (PBP)	8 months
post-operative complications	fatigue (BFI) Brief Fatigue Inventory questionnaire	8 months
post-operative complications	history of fall	8 months
post-operative complications	pain (visual analogic scale for pain 0 to 10)	8 months
post-operative complications	hours of mobility (actimetry)	8 months
post-operative complications	hours of daily rest (actimetry) measured during 3 consecutives days	8 months
post-operative complications	Actimetry	8 months
post-operative complications	nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )	8 months
post-operative complications	cognitive status (normal or not)	8 months
post-operative complications	polymedication (≥5 / day)	8 months
post-operative complications	comorbidities (updated charlson)	8 months
post-operative complications	inappropriate prescriptions (STOPP)	8 months
impedancemetric value	Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value	2 months
sarcopenic status	evolution of sarcopenic status	between baseline; preoperative and at 6 months post-operative
quality of life scores	EORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items)	preoperative and 6-month post-operative

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: PLoS One. 2014;9(7):e103907. de'Liguori Carino, Nicola [corrected to Carino, Nicola de'Liguori]. PLoS One. 2016;11(1):e0147993.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; elderly
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Sarcopenia
• Other Study ID Numbers: SAMPHYR 16-181.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No