Clinical trial NCT06721260: Metabolism Evaluation Through Resting Indirect Calorimetry in Bladder Cancer (METRICS)
Official title: METRICS Study: Metabolic Evaluation Through Resting Indirect Calorimetry in Bladder Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: Bladder cancer
resting energy expenditure
cachexia
growth differentiation factor 15 (GDF-15)
Nutrition status
radical cystectomy
neoadjuvant chemotherapy
body composition
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential patients will be scheduled for treatment (chemotherapy and radical cystectomy) for bladder cancer at the University of Kansas Health System.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess Resting Energy Expenditure (REE) changes across key treatment milestones.
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Secondary outcomes:
measure: Blood biomarkers
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
measure: Inflammation marker
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
measure: Immune inflammation marker
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
measure: Body composition
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
measure: Nutrition assessment
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
measure: Grip strength measurement
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
measure: Quality of Life (QOL) and Fatigue assessment
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
measure: Quality of Life (QOL) during bladder cancer treatment assessment
timeFrame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill M Hamilton-Reeves, PhD, RD, CSO
role: PRINCIPAL_INVESTIGATOR
References: