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

NCT ID: NCT06721260

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-21

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jill Hamilton-Reeves, PhD RD LD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill M Hamilton-Reeves, PhD, RD, CSO

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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

Role: CONTACT

913-588-7650

Misty D Bechtel, BA, CCRP

Role: CONTACT

913-945-5037

Facility Contacts

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Misty Bechtel

Role: primary

913-945-7519

Misty Bechtel

Role: primary

Other Identifiers

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STUDY00160673

Identifier Type: -

Identifier Source: org_study_id

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