The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

Urinary Bladder Neoplasm Clinical Trial

Official title:

The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144270
• Other study ID #: 70298
• Status: Recruiting
• Start date: November 18, 2019
• Est. completion date: April 2021

Study information

• Verified date: November 2019
• Source: Rigshospitalet, Denmark
• Contact: Lise Hoej Omland, MD
• Phone: +45 35450782
• Email: lise.hoej.omland[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. It also evaluates biomarkers for sarcopenia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Age = 18 år

• Histologically verified cancer of the renal pelvis, ureter, bladder or urethra regardless of type of histology

• ECOG performance status 0 - 3

• Meet the requirements for receiving oncological treatment (neoadjuvant chemotherapy for localized disease, chemotherapy or immunotherapy for disseminated disease).

Exclusion Criteria:

• Age < 18

Related Conditions & MeSH terms

• Neoplasms
• Urinary Bladder Neoplasm
• Urinary Bladder Neoplasms

Intervention

Other:
• Evaluation of muscle mass and muscle function
Included patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment.

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Beckett Foundation, Merck Sharp & Dohme Corp., Onkologisk Forskningsfond, Roche Pharma AG

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	We will describe if muscle mass at baseline is correlated to completion of planned systemic oncological treatment	Up to 36 months
Secondary	Muscle strength	We will describe if muscle strength at baseline is correlated to completion of planned systemic oncological treatment	Up to 36 months
Secondary	Muscle mass changes during systemic oncological treatment	We will describe if muscle mass change during systemic oncological treatment	Up to 36 months
Secondary	Muscle strength changes during systemic oncological treatment	We will describe if muscle mass change during systemic oncological treatment	Up to 36 months