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

NCT06721260 | Recruiting

• 1 other identifier: STUDY00160673
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Bladder Cancer

Keywords

Bladder cancer; resting energy expenditure; cachexia; growth differentiation factor 15 (GDF-15); Nutrition status; radical cystectomy; neoadjuvant chemotherapy; body composition

Outcome Measures

Primary Outcomes (1)

• To assess Resting Energy Expenditure (REE) changes across key treatment milestones.

  Resting Energy Expenditure (REE) will be measured using indirect calorimetry before and after chemotherapy and radical cystectomy and will be associated with clinical outcomes.

  From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.

Secondary Outcomes (8)

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (2)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Cachexia

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Jill M Hamilton-Reeves, PhD, RD, CSO

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill M. Hamilton-Reeves, PhD, RD, CSO

CONTACT

913-588-7650; jhamilton-reeves@kumc.edu

Misty D Bechtel, BA, CCRP

CONTACT

913-945-5037; mbechtel2@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 6, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (2)