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

Bladder Cancer Clinical Trial

— SAMPHYR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03362801
• Other study ID #: SAMPHYR 16-181.
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: University Hospital, Caen
• Contact: françois fournel
• Phone: +33231065488
• Email: fournel-f[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bladder Cancer
• Sarcopenia
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Caen University Hospital	Caen
France	APHM	Marseille
France	Rouen UH	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

References & 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 — View Citation

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 coh — View Citation

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. Ca — View Citation

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. — View Citation

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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative morbidity	evaluated according to Clavien-Dindo classification	at 30 days
Primary	post-operative mortality		at 30 days
Secondary	post-operative complications	Impact of dependancy (PS / ADL / IADL)	8 months
Secondary	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
Secondary	post-operative complications	physical performance (PBP)	8 months
Secondary	post-operative complications	fatigue (BFI) Brief Fatigue Inventory questionnaire	8 months
Secondary	post-operative complications	history of fall	8 months
Secondary	post-operative complications	pain (visual analogic scale for pain 0 to 10)	8 months
Secondary	post-operative complications	hours of mobility (actimetry)	8 months
Secondary	post-operative complications	hours of daily rest (actimetry) measured during 3 consecutives days	8 months
Secondary	post-operative complications	Actimetry	8 months
Secondary	post-operative complications	nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )	8 months
Secondary	post-operative complications	cognitive status (normal or not)	8 months
Secondary	post-operative complications	polymedication (=5 / day)	8 months
Secondary	post-operative complications	comorbidities (updated charlson)	8 months
Secondary	post-operative complications	inappropriate prescriptions (STOPP)	8 months
Secondary	impedancemetric value	Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value	2 months
Secondary	sarcopenic status	evolution of sarcopenic status	between baseline; preoperative and at 6 months post-operative
Secondary	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