The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

• Conditions: Urinary Bladder Neoplasm
• Interventions: Other: Evaluation of muscle mass and muscle function

• Registration Number: NCT04144270
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Status Verified: 2019-11
• Study Start: 2019-11-18
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Included patients	Evaluation of muscle mass and muscle function	One-arm study. All included patients will have muscle mass and muscle function evaluated

Primary Outcome Measures

Name	Time	Method
Muscle mass	Up to 36 months	We will describe if muscle mass at baseline is correlated to completion of planned systemic oncological treatment

Secondary Outcome Measures

Name	Time	Method
Muscle strength	Up to 36 months	We will describe if muscle strength at baseline is correlated to completion of planned systemic oncological treatment
Muscle mass changes during systemic oncological treatment	Up to 36 months	We will describe if muscle mass change during systemic oncological treatment
Muscle strength changes during systemic oncological treatment	Up to 36 months	We will describe if muscle mass change during systemic oncological treatment

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark