METRICS Study: Metabolic Evaluation Through Resting Indirect Calorimetry in Bladder Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To assess Resting Energy Expenditure (REE) changes across key treatment milestones.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
To assess Resting Energy Expenditure (REE) changes across key treatment milestones.
Time Frame: 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 Outcomes
- Blood biomarkers(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
- Inflammation marker(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
- Immune inflammation marker(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
- Body composition(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
- Nutrition assessment(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
- Grip strength measurement(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
- Quality of Life (QOL) and Fatigue assessment(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
- Quality of Life (QOL) during bladder cancer treatment assessment(From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.)
Investigators
Jill Hamilton-Reeves, PhD RD LD
Professor
University of Kansas Medical Center