Metabolism Evaluation Through Resting Indirect Calorimetry in Bladder Cancer (METRICS)

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT06721260
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

This study is being done to learn more about energy needs and muscle function during treatment for bladder cancer. These insights can help improve future patient care. The study team found in a previous study that resting energy can be different than what estimates show. Patients with bladder cancer are known to suffer a decline in physical resilience over time. Monitoring patients to understand these changes better could help design future treatments with these vulnerabilities in mind.

Detailed Description

The investigators' long-term goal is to improve cachexia treatment for patients with cancer. The project is significant because identifying cachexia earlier in its onset allows for earlier and more successful treatment. Major barriers to early detection and treatment are: 1) clear specific lab tests to confirm the diagnosis and 2) identifying when resting energy expenditure (REE) increases. It is the investigators' expectation that at the completion of these descriptive studies, key factors will be identified to guide earlier detection and treatment of cachexia. Platinum-based chemotherapy and surgery are a dual-phase treatment regimen to treat bladder cancer that has a high risk of worsening cachexia compared to other cancer types not requiring such an intensive treatment regimen. Inhibition of Growth differentiation factor 15 (GDF-15) is a promising preventive strategy against cachexia in patients with bladder cancer. Understanding GDF-15 and REE changes over the course of treatment could inform proactive rather than reactive strategies to support the health of these patients and translate to patients with other types of cancer. The objective of this application is to assess changes in GDF-15 and REE levels during the treatment course for advanced bladder cancer.

Study Timeline

• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-06
• Study Start: 2025-01-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

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

Inclusion Criteria

• Confirmed cancer diagnosis
• Scheduled for platinum-based chemotherapy followed by radical cystectomy
• Adequate renal and cardiac function for platinum-based chemotherapy

Exclusion Criteria

• Prior chemotherapy or radiotherapy for bladder cancer
• Severe cardiac, renal, hepatic, respiratory or metabolic diseases
• Pregnant or breastfeeding
• Uncontrolled conditions that could affect study outcomes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess Resting Energy Expenditure (REE) changes across key treatment milestones.	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	Resting Energy Expenditure (REE) will be measured using indirect calorimetry before and after chemotherapy and radical cystectomy and will be associated with clinical outcomes.

Secondary Outcome Measures

Name	Time	Method
Blood biomarkers	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	Blood will be collected at study visits and growth differentiation factor-15 (GDF-15) concentration will be evaluated.
Inflammation marker	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	Blood will be collected at study visits and Interleukin-6 (IL-6) concentration will be evaluated.
Immune inflammation marker	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	Blood will be collected at study visits and tumor necrosis factor alpha (TNFa) concentration will be evaluated.
Body composition	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	Changes in muscle and fat mass will be assessed using dual-energy X-ray (DXA) at study visits.
Nutrition assessment	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	The Patient-Generated Subjective Global Assessment (PG-SGA) and 24-hour dietary recalls will be administered in an interview format by trained study personnel. These will take place at study visits.
Grip strength measurement	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	A hand dynamometer will be used to measure grip strength at study visits.
Quality of Life (QOL) and Fatigue assessment	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	FACIT-Fatigue questionnaires will be administered to evaluate changes in health-related quality of life (HRQOL) at study visits.
Quality of Life (QOL) during bladder cancer treatment assessment	From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.	FACT-Bl-Cys questionnaires will be administered to evaluate changes in health-related quality of life (HRQOL) at study visits.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States