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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarcopenic | Other | sarcopenic status the day before cystectomy. |
|
| not sarcopenic | Other | sarcopenic status the day before cystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sarcopenia and mobility measurement | Diagnostic 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 |
| Measure | Description | Time Frame |
|---|---|---|
| post-operative morbidity | evaluated according to Clavien-Dindo classification | at 30 days |
| post-operative mortality | at 30 days |
| 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 |
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Inclusion Criteria:
confirmed urothelial bladder carcinoma ( RTUV)
Exclusion Criteria:
Life expectancy <6 months
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| françois fournel | Contact | +33231065488 | fournel-f@chu-caen.fr | |
| helene legros | Contact | legros-h@chu-caen.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caen University Hospital | Recruiting | Caen | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15093567 | Result | 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. | |
| 24475186 | Result | 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. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D001749 | Urinary Bladder Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 |
| APHM | Recruiting | Marseille | France |
|
| Rouen UH | Suspended | Rouen | France |
| 26882087 | Result | 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. |
| 24840856 | Result | 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. |
| 24423437 | Result | 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. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |