Clinical trial NCT03362801: SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
Official title: SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Bladder Cancer
Keywords: physical activity
elderly
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 69
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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).

Primary outcomes:
measure: post-operative morbidity
timeFrame: at 30 days
measure: post-operative mortality
timeFrame: at 30 days
Secondary outcomes:
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: post-operative complications
timeFrame: 8 months
measure: impedancemetric value
timeFrame: 2 months
measure: sarcopenic status
timeFrame: between baseline; preoperative and at 6 months post-operative
measure: quality of life scores
timeFrame: preoperative and 6-month post-operative
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
city: Marseille
country: France
facility: APHM
city: Rouen
country: France
facility: Rouen UH
Study officials:
References:
citation: 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.
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 cohort study. PLoS One. 2014 Jan 24;9(1):e86863. doi: 10.1371/journal.pone.0086863. eCollection 2014.
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.
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. Cancer. 2014 Sep 15;120(18):2910-8. doi: 10.1002/cncr.28798. Epub 2014 May 19.
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 2014 Jan 11.