search
Back to results

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

Primary Purpose

Sarcopenia, Bladder Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sarcopenia and mobility measurement
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcopenia focused on measuring physical activity, elderly

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Caen University HospitalRecruiting
  • APHM
  • Rouen UHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Sarcopenic

not sarcopenic

Arm Description

sarcopenic status the day before cystectomy.

sarcopenic status the day before cystectomy.

Outcomes

Primary Outcome Measures

post-operative morbidity
evaluated according to Clavien-Dindo classification
post-operative mortality

Secondary Outcome Measures

post-operative complications
Impact of dependancy (PS / ADL / IADL)
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
post-operative complications
physical performance (PBP)
post-operative complications
fatigue (BFI) Brief Fatigue Inventory questionnaire
post-operative complications
history of fall
post-operative complications
pain (visual analogic scale for pain 0 to 10)
post-operative complications
hours of mobility (actimetry)
post-operative complications
hours of daily rest (actimetry) measured during 3 consecutives days
post-operative complications
Actimetry
post-operative complications
nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )
post-operative complications
cognitive status (normal or not)
post-operative complications
polymedication (≥5 / day)
post-operative complications
comorbidities (updated charlson)
post-operative complications
inappropriate prescriptions (STOPP)
impedancemetric value
Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value
sarcopenic status
evolution of sarcopenic status
quality of life scores
EORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items)

Full Information

First Posted
March 7, 2017
Last Updated
September 4, 2023
Sponsor
University Hospital, Caen
search

1. Study Identification

Unique Protocol Identification Number
NCT03362801
Brief Title
SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
Acronym
SAMPHYR
Official Title
SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Bladder Cancer
Keywords
physical activity, elderly

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sarcopenic
Arm Type
Other
Arm Description
sarcopenic status the day before cystectomy.
Arm Title
not sarcopenic
Arm Type
Other
Arm Description
sarcopenic status the day before cystectomy.
Intervention Type
Diagnostic Test
Intervention Name(s)
sarcopenia and mobility measurement
Intervention Description
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 Measure Information:
Title
post-operative morbidity
Description
evaluated according to Clavien-Dindo classification
Time Frame
at 30 days
Title
post-operative mortality
Time Frame
at 30 days
Secondary Outcome Measure Information:
Title
post-operative complications
Description
Impact of dependancy (PS / ADL / IADL)
Time Frame
8 months
Title
post-operative complications
Description
physical activity scores (QAPPA) Questionnaire d'activité physique pour les personnes âgées in French validated in French population - total score is used
Time Frame
8 months
Title
post-operative complications
Description
physical performance (PBP)
Time Frame
8 months
Title
post-operative complications
Description
fatigue (BFI) Brief Fatigue Inventory questionnaire
Time Frame
8 months
Title
post-operative complications
Description
history of fall
Time Frame
8 months
Title
post-operative complications
Description
pain (visual analogic scale for pain 0 to 10)
Time Frame
8 months
Title
post-operative complications
Description
hours of mobility (actimetry)
Time Frame
8 months
Title
post-operative complications
Description
hours of daily rest (actimetry) measured during 3 consecutives days
Time Frame
8 months
Title
post-operative complications
Description
Actimetry
Time Frame
8 months
Title
post-operative complications
Description
nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )
Time Frame
8 months
Title
post-operative complications
Description
cognitive status (normal or not)
Time Frame
8 months
Title
post-operative complications
Description
polymedication (≥5 / day)
Time Frame
8 months
Title
post-operative complications
Description
comorbidities (updated charlson)
Time Frame
8 months
Title
post-operative complications
Description
inappropriate prescriptions (STOPP)
Time Frame
8 months
Title
impedancemetric value
Description
Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value
Time Frame
2 months
Title
sarcopenic status
Description
evolution of sarcopenic status
Time Frame
between baseline; preoperative and at 6 months post-operative
Title
quality of life scores
Description
EORTC QLQ-ELD14 (assessment of health-related quality of life elderly patients with cancer with 14 items)
Time Frame
preoperative and 6-month post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
françois fournel
Phone
+33231065488
Email
fournel-f@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
helene legros
Email
legros-h@chu-caen.fr
Facility Information:
Facility Name
Caen University Hospital
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bérengère Beauplet, PhD
Email
beauplet-b@chu-caen.fr
Facility Name
APHM
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Nouzergues
Email
Emilie.NOUGUEREDE@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Anne-Laure Couderc, MD
Facility Name
Rouen UH
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maeva Bizon
Email
Maeva.Bizon@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Christian Pfister

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15093567
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.
Results Reference
result
PubMed Identifier
24475186
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. Erratum In: PLoS One. 2014;9(7):e103907. de'Liguori Carino, Nicola [corrected to Carino, Nicola de'Liguori]. PLoS One. 2016;11(1):e0147993.
Results Reference
result
PubMed Identifier
26882087
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.
Results Reference
result
PubMed Identifier
24840856
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.
Results Reference
result
PubMed Identifier
24423437
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs