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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood biomarkers | Blood will be collected at study visits and growth differentiation factor-15 (GDF-15) concentration will be evaluated. | From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy. |
| Inflammation marker |
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Inclusion Criteria:
Exclusion Criteria:
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Potential patients will be scheduled for treatment (chemotherapy and radical cystectomy) for bladder cancer at the University of Kansas Health System.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Jill M Hamilton-Reeves, PhD, RD, CSO | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Whole blood, serum
Blood will be collected at study visits and Interleukin-6 (IL-6) concentration will be evaluated.
| 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. | 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. | 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. | 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. | 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. | 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. | From enrollment, prior to chemotherapy, to 3 weeks after radical cystectomy. |
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |