SarcopeniaSAMPHYRNCT03362801
SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
A study testing sarcopenia and mobility measurement in people with Sarcopenia and Bladder Cancer, run by University Hospital, Caen at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia, Bladder Cancer
- What is being tested?
- sarcopenia and mobility measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesFrance
- Study dates
- 30 Oct 2017to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
helene legros contact
France3 sites, 2 recruiting
- Recruiting
Caen University Hospital
Caen
Bérengère Beauplet, PhD, beauplet-b@chu-caen.fr
- Recruiting
APHM
Marseille
Emilie Nouzergues, Emilie.NOUGUEREDE@ap-hm.fr
Anne-Laure Couderc, MD
- Suspended
Rouen UH
Rouen
About this study
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).
Read more
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
- Conditions
- Sarcopenia, Bladder Cancer
- Being tested
- sarcopenia and mobility measurement
- Keywords
- physical activity, elderly
- Medical subject headings
- Sarcopenia, Urinary Bladder Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcopenia and mobility measurementDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic | Other | sarcopenic status the day before cystectomy. Receives: Diagnostic Test: sarcopenia and mobility measurement |
| not sarcopenic | Other | sarcopenic status the day before cystectomy. Receives: Diagnostic Test: sarcopenia and mobility measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative morbidity
evaluated according to Clavien-Dindo classification
Measured: at 30 days
post-operative mortality
Measured: at 30 days
Secondary outcomes (17)
post-operative complications
Impact of dependancy (PS / ADL / IADL)
Measured: 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
Measured: 8 months
post-operative complications
physical performance (PBP)
Measured: 8 months
post-operative complications
fatigue (BFI) Brief Fatigue Inventory questionnaire
Measured: 8 months
post-operative complications
history of fall
Measured: 8 months
post-operative complications
pain (visual analogic scale for pain 0 to 10)
Measured: 8 months
post-operative complications
hours of mobility (actimetry)
Measured: 8 months
post-operative complications
hours of daily rest (actimetry) measured during 3 consecutives days
Measured: 8 months
post-operative complications
Actimetry
Measured: 8 months
post-operative complications
nutritional status (nutritional grade 2 or 4 according to SFNEP Société Francophone Nutrition Clinique et Métabolisme )
Measured: 8 months
post-operative complications
cognitive status (normal or not)
Measured: 8 months
post-operative complications
polymedication (≥5 / day)
Measured: 8 months
post-operative complications
comorbidities (updated charlson)
Measured: 8 months
post-operative complications
inappropriate prescriptions (STOPP)
Measured: 8 months
impedancemetric value
Concordance of values (attribution of sarcopenic / non-sarcopenic groups) with impedancemetric value
Measured: 2 months
sarcopenic status
evolution of sarcopenic status
Measured: 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)
Measured: preoperative and 6-month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start30 Oct 2017
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362801
- Sponsor's protocol ID
- SAMPHYR 16-181.
- Acronym
- SAMPHYR
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2017
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15093567Huisman 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.
PubMed 24475186Shachar 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.
PubMed 26882087Psutka 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.
PubMed 24840856Smith 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.
PubMed 24423437
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SArcopenia, Mobility, PHYsical Activity and Post-operative Risk of Bladder Carcinoma in the Elderly
- ClinicalTrials.gov ID
- NCT03362801
- Acronym / sponsor ID
- SAMPHYR / SAMPHYR 16-181.
- Conditions
- Sarcopenia, Bladder Cancer
- Keywords
- physical activity, elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic | Other | Diagnostic Test: sarcopenia and mobility measurementsarcopenic status the day before cystectomy. |
| not sarcopenic | Other | Diagnostic Test: sarcopenia and mobility measurementsarcopenic status the day before cystectomy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- confirmed urothelial bladder carcinoma ( RTUV)
Key exclusion criteria (3 listed)
- Life expectancy <6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sarcopenia and mobility measurementwalking 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 | Diagnostic test | Sarcopenic, not sarcopenic |
Primary outcome
post-operative morbidity
Time frame: at 30 days
evaluated according to Clavien-Dindo classification
post-operative mortality
Time frame: at 30 days
17 secondary outcomes
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
post-operative complications
Time frame: 8 months
impedancemetric value
Time frame: 2 months
sarcopenic status
Time frame: between baseline; preoperative and at 6 months post-operative
quality of life scores
Time frame: preoperative and 6-month post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Results publication: PubMed 15093567Audisio 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 publication: PubMed 24475186Huisman 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.
- Results publication: PubMed 26882087Shachar 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 publication: PubMed 24840856Psutka 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 publication: PubMed 24423437Smith 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.
- Individual participant dataSharing planned: No
Related trials for Sarcopenia
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
helene legros contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sarcopenia and mobility measurement in people with Sarcopenia and Bladder Cancer, run by University Hospital, Caen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact françois fournel (+33231065488, fournel-f@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative morbidity (time frame: at 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362801, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.