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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362801
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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


Condition or disease Intervention/treatment Phase
Sarcopenia Bladder Cancer Diagnostic Test: sarcopenia and mobility measurement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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


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





Primary Outcome Measures :
  1. post-operative morbidity [ Time Frame: at 30 days ]
    evaluated according to Clavien-Dindo classification

  2. post-operative mortality [ Time Frame: at 30 days ]

Secondary Outcome Measures :
  1. post-operative complications [ Time Frame: 8 months ]
    Impact of dependancy (PS / ADL / IADL)

  2. post-operative complications [ Time Frame: 8 months ]
    physical activity scores (QAPPA) Questionnaire d'activité physique pour les personnes âgées in French validated in French population - total score is used

  3. post-operative complications [ Time Frame: 8 months ]
    physical performance (PBP)

  4. post-operative complications [ Time Frame: 8 months ]
    fatigue (BFI) Brief Fatigue Inventory questionnaire

  5. post-operative complications [ Time Frame: 8 months ]
    history of fall

  6. post-operative complications [ Time Frame: 8 months ]
    pain (visual analogic scale for pain 0 to 10)

  7. post-operative complications [ Time Frame: 8 months ]
    hours of mobility (actimetry)

  8. post-operative complications [ Time Frame: 8 months ]
    hours of daily rest (actimetry) measured during 3 consecutives days

  9. post-operative complications [ Time Frame: 8 months ]
    Actimetry

  10. post-operative complications [ Time Frame: 8 months ]
    nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )

  11. post-operative complications [ Time Frame: 8 months ]
    cognitive status (normal or not)

  12. post-operative complications [ Time Frame: 8 months ]
    polymedication (≥5 / day)

  13. post-operative complications [ Time Frame: 8 months ]
    comorbidities (updated charlson)

  14. post-operative complications [ Time Frame: 8 months ]
    inappropriate prescriptions (STOPP)

  15. impedancemetric value [ Time Frame: 2 months ]
    Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value

  16. sarcopenic status [ Time Frame: between baseline; preoperative and at 6 months post-operative ]
    evolution of sarcopenic status

  17. quality of life scores [ Time Frame: preoperative and 6-month post-operative ]
    EORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362801


Contacts
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Contact: françois fournel +33231065488 fournel-f@chu-caen.fr
Contact: helene legros legros-h@chu-caen.fr

Locations
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France
Caen University Hospital Recruiting
Caen, France
Contact: Bérengère Beauplet, PhD       beauplet-b@chu-caen.fr   
Rouen UH Recruiting
Rouen, France
Contact: Maeva Bizon       Maeva.Bizon@chu-rouen.fr   
Principal Investigator: Christian Pfister         
Sponsors and Collaborators
University Hospital, Caen
Publications of Results:

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT03362801    
Other Study ID Numbers: SAMPHYR 16-181.
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
physical activity
elderly
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Sarcopenia
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical