NCT03757949Active, not recruitingPhase 3
Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery
A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
This phase III trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery. Improving nutrition before and after surgery may reduce the infections and other problems that sometimes occur after surgery.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- First submitted
- 1 Oct 2018
- Start date
- 5 Mar 2019
- Primary completion date
- 1 Jan 2024
- Lead sponsor
- SWOG Cancer Research Network
- Diseases
- Bladder cancer
- NCT number
- NCT03757949
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 203
- From 5 Mar 2019 to the primary completion date, 1 Jan 2024
- 46 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Patients must have a tissue diagnosis of primary cell carcinoma of the bladder by transurethral resection of bladder tumor (TURBT) or partial cystectomy; patients may not have any evidence of unresectable disease or metastatic disease as assessed by exam under anesthesia or imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], positron-emission tomography \[PET\])
- There must be plans for the cystectomy to be performed within 28 calendar days after registration
- Surgery must be planned to be performed under pre-approved, study-specific surgical guidelines
- Patients must have completed any neoadjuvant chemotherapy or immunotherapy (intravesical or systemic) \>= 14 calendar days prior to registration and any toxicities resolved to at least grade 2
- Patients may have a history of radiation therapy; radiation therapy must have been completed \>= 180 days prior to registration
- Patients may have a history of prior partial cystectomy; prior partial cystectomy must have been completed at least 180 days prior to registration
- Patients with planned adjuvant chemotherapy within 90 days after radical cystectomy will not be eligible
- Patients must be able to swallow liquid and have no refractory nausea, vomiting, malabsorption, or significant small bowel resection that would preclude adequate absorption; patients on tube feeding are not eligible
- Patients must have their baseline nutrition status assessed using the Scored Patient-Generated Subjective Global Assessment (PG-SGA) by a clinician or licensed healthcare practitioner (trained physician, nurse, or dietician) within 14 days prior to registration and must not have a global category rating of stage C (severely malnourished)
- Patients must not have galactosemia
- Patients must not have known active viral infections such as human immunodeficiency virus (HIV) or hepatitis, as these chronic viral infections may cause cachexia and immunodeficiency and thus alter the biology regarding the study endpoints
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years; prostate cancer found at cystectomy would not be considered a prior malignancy
- Patients must not be pregnant or nursing as the conditions preclude candidacy for radical cystectomy
- Patients must consent and be willing to have specimens collected and submitted
- Patients must be offered the opportunity to participate in additional specimen banking
- Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
- Patients must consent and provide their telephone contact information for four 24-hour dietary recall phone interviews to be conducted by staff at the Exercise, Diet, Genitourinary, \& Endocrinology Laboratory (EDGE) Research Laboratory
- Patients must be able to understand and speak English and/or Spanish because the dietary recall phone interviews will only be conducted in English or Spanish
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Saint Joseph Mercy Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Lehigh Valley Hospital - Muhlenberg Coordinator of this site? Confirm its status | Bethlehem | United States | Unknown status |
| Saint Joseph Mercy Brighton Coordinator of this site? Confirm its status | Brighton | United States | Unknown status |
| IHA Hematology Oncology Consultants-Brighton Coordinator of this site? Confirm its status | Brighton | United States | Unknown status |
| Saint Joseph Mercy Canton Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| IHA Hematology Oncology Consultants-Canton Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| IHA Hematology Oncology Consultants-Chelsea Coordinator of this site? Confirm its status | Chelsea | United States | Unknown status |
| Saint Joseph Mercy Chelsea Coordinator of this site? Confirm its status | Chelsea | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Decatur Memorial Hospital Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Ascension Saint John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| City of Hope Comprehensive Cancer Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Pocono Medical Center Coordinator of this site? Confirm its status | East Stroudsburg | United States | Unknown status |
| University of Kansas Clinical Research Center Coordinator of this site? Confirm its status | Fairway | United States | Unknown status |
| Hurley Medical Center Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| Genesys Hurley Cancer Institute Coordinator of this site? Confirm its status | Flint | United States | Unknown status |
| University of Texas Medical Branch Coordinator of this site? Confirm its status | Galveston | United States | Unknown status |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Coordinator of this site? Confirm its status | Grosse Pointe Woods | United States | Unknown status |
| Lehigh Valley Hospital-Hazleton Coordinator of this site? Confirm its status | Hazleton | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Sparrow Hospital Coordinator of this site? Confirm its status | Lansing | United States | Unknown status |
| UTMB Cancer Center at Victory Lakes Coordinator of this site? Confirm its status | League City | United States | Unknown status |
| Los Angeles County-USC Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Coordinator of this site? Confirm its status | Metairie | United States | Unknown status |
| USC Norris Oncology/Hematology-Newport Beach Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| University of Kansas Hospital-Indian Creek Campus Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Keck Medical Center of USC Pasadena Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Maine Medical Center-Bramhall Campus Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth University/Massey Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Maine Medical Center- Scarborough Campus Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Henry Ford West Bloomfield Hospital Coordinator of this site? Confirm its status | West Bloomfield | United States | Unknown status |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Unknown status |
| Huron Gastroenterology PC Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
| IHA Hematology Oncology Consultants-Ann Arbor Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.