Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE March 7, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE October 30, 2017
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • post-operative morbidity [ Time Frame: at 30 days ]
    evaluated according to Clavien-Dindo classification
  • post-operative mortality [ Time Frame: at 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • post-operative morbidity [ Time Frame: at 30 days ]
    Post-operative morbidity at 30 days will be evaluated according to Clavien-Dindo classification
  • post-operative mortality [ Time Frame: at 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • post-operative complications [ Time Frame: 8 months ]
    Impact of dependancy (PS / ADL / IADL)
  • 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
  • post-operative complications [ Time Frame: 8 months ]
    physical performance (PBP)
  • post-operative complications [ Time Frame: 8 months ]
    fatigue (BFI) Brief Fatigue Inventory questionnaire
  • post-operative complications [ Time Frame: 8 months ]
    history of fall
  • post-operative complications [ Time Frame: 8 months ]
    pain (visual analogic scale for pain 0 to 10)
  • post-operative complications [ Time Frame: 8 months ]
    hours of mobility (actimetry)
  • post-operative complications [ Time Frame: 8 months ]
    hours of daily rest (actimetry) measured during 3 consecutives days
  • post-operative complications [ Time Frame: 8 months ]
    Actimetry
  • post-operative complications [ Time Frame: 8 months ]
    nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )
  • post-operative complications [ Time Frame: 8 months ]
    cognitive status (normal or not)
  • post-operative complications [ Time Frame: 8 months ]
    polymedication (≥5 / day)
  • post-operative complications [ Time Frame: 8 months ]
    comorbidities (updated charlson)
  • post-operative complications [ Time Frame: 8 months ]
    inappropriate prescriptions (STOPP)
  • impedancemetric value [ Time Frame: 2 months ]
    Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value
  • sarcopenic status [ Time Frame: between baseline; preoperative and at 6 months post-operative ]
    evolution of sarcopenic status
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • post-operative complications [ Time Frame: 8 months ]
    Impact of dependancy (PS / ADL / IADL)
  • 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
  • post-operative complications [ Time Frame: 8 months ]
    physical performance (PBP)
  • post-operative complications [ Time Frame: 8 months ]
    fatigue (BFI) Brief Fatigue Inventory questionnaire
  • post-operative complications [ Time Frame: 8 months ]
    history of fall
  • post-operative complications [ Time Frame: 8 months ]
    pain (visual analogic scale for pain 0 to 10)
  • post-operative complications [ Time Frame: 8 months ]
    hours of mobility (actimetry)
  • post-operative complications [ Time Frame: 8 months ]
    hours of daily rest (actimetry) measured during 3 consecutives days
  • post-operative complications [ Time Frame: 8 months ]
    Actimetry
  • post-operative complications [ Time Frame: 8 months ]
    nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )
  • post-operative complications [ Time Frame: 8 months ]
    cognitive status (normal or not)
  • post-operative complications [ Time Frame: 8 months ]
    polymedication (≥5 / day)
  • post-operative complications [ Time Frame: 8 months ]
    comorbidities (updated charlson)
  • post-operative complications [ Time Frame: 8 months ]
    inappropriate prescriptions (STOPP)
  • impedancemetric value [ Time Frame: 2 months ]
    Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value
  • sarcopenic status [ Time Frame: baseline, ]
    evolution of sarcopenic status
  • sarcopenic status [ Time Frame: preoperative ]
    evolution of sarcopenic status
  • sarcopenic status [ Time Frame: at 6 months post-operative ]
    evolution of sarcopenic status
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
Official Title  ICMJE SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Sarcopenia
  • Bladder Cancer
Intervention  ICMJE 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

Study Arms  ICMJE
  • Sarcopenic
    sarcopenic status the day before cystectomy.
    Intervention: Diagnostic Test: sarcopenia and mobility measurement
  • not sarcopenic
    sarcopenic status the day before cystectomy.
    Intervention: Diagnostic Test: sarcopenia and mobility measurement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 29, 2017)
69
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: françois fournel +33231065488 fournel-f@chu-caen.fr
Contact: helene legros legros-h@chu-caen.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362801
Other Study ID Numbers  ICMJE SAMPHYR 16-181.
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Caen
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP