Bladder CancerMETRICSNCT06721260
Metabolism Evaluation Through Resting Indirect Calorimetry in Bladder Cancer (METRICS)
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jan 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential patients will be scheduled for treatment (chemotherapy and radical cystectomy) for bladder cancer at the University of Kansas Health System.
Who may be able to join
- Confirmed cancer diagnosis
- Scheduled for platinum-based chemotherapy followed by radical cystectomy
- Adequate renal and cardiac function for platinum-based chemotherapy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Misty Bechtel, 913-945-7519, mbechtel@kumc.edu
Jill Hamilton-Reeves, PhD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Misty Bechtel
Jill Hamilton-Reeves
About this study
Official title: METRICS Study: Metabolic Evaluation Through Resting Indirect Calorimetry in Bladder Cancer
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.
Read the 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.
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, resting energy expenditure, cachexia, growth differentiation factor 15 (GDF-15), Nutrition status, radical cystectomy, neoadjuvant chemotherapy, body composition
- Medical subject headings
- Urinary Bladder Neoplasms, Cachexia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Secondary outcomes (8)
Blood biomarkers
Blood will be collected at study visits and growth differentiation factor-15 (GDF-15) concentration will be evaluated.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Inflammation marker
Blood will be collected at study visits and Interleukin-6 (IL-6) concentration will be evaluated.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Immune inflammation marker
Blood will be collected at study visits and tumor necrosis factor alpha (TNFa) concentration will be evaluated.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Body composition
Changes in muscle and fat mass will be assessed using dual-energy X-ray (DXA) at study visits.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Nutrition assessment
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.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Grip strength measurement
A hand dynamometer will be used to measure grip strength at study visits.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Quality of Life (QOL) and Fatigue assessment
FACIT-Fatigue questionnaires will be administered to evaluate changes in health-related quality of life (HRQOL) at study visits.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Quality of Life (QOL) during bladder cancer treatment assessment
FACT-Bl-Cys questionnaires will be administered to evaluate changes in health-related quality of life (HRQOL) at study visits.
Measured: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start21 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center
- Investigators
- Jill M Hamilton-Reeves, PhD, RD, CSO, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721260
- Sponsor's protocol ID
- STUDY00160673
- Acronym
- METRICS
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- METRICS Study: Metabolic Evaluation Through Resting Indirect Calorimetry in Bladder Cancer
- ClinicalTrials.gov ID
- NCT06721260
- Acronym / sponsor ID
- METRICS / STUDY00160673
- Conditions
- Bladder Cancer
- Keywords
- Bladder cancer, resting energy expenditure, cachexia, growth differentiation factor 15 (GDF-15), Nutrition status, radical cystectomy, neoadjuvant chemotherapy, body composition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential patients will be scheduled for treatment (chemotherapy and radical cystectomy) for bladder cancer at the University of Kansas Health System.
Key inclusion criteria (3 listed)
- Confirmed cancer diagnosis
- Scheduled for platinum-based chemotherapy followed by radical cystectomy
- Adequate renal and cardiac function for platinum-based chemotherapy
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Blood biomarkers
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Inflammation marker
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Immune inflammation marker
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Body composition
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Nutrition assessment
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Grip strength measurement
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Quality of Life (QOL) and Fatigue assessment
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Quality of Life (QOL) during bladder cancer treatment assessment
Time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jill M Hamilton-Reeves, PhD, RD, CSO principal investigator
University of Kansas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by University of Kansas Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill M. Hamilton-Reeves, PhD, RD, CSO (913-588-7650, jhamilton-reeves@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess Resting Energy Expenditure (REE) changes across key treatment milestones. (time frame: From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.