Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Bladder Carcinoma

In brief

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.

Key facts

Study ID: NCT03757949
Run by: SWOG Cancer Research Network
People needed: 203
Starts: 2019-03-05
Expected to finish: 2027-01-01
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

City of Hope Comprehensive Cancer Center — Duarte, California, United States
Los Angeles County-USC Medical Center — Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California, United States
Keck Medical Center of USC Pasadena — Pasadena, California, United States
University of Colorado Hospital — Aurora, Colorado, United States
Mayo Clinic in Florida — Jacksonville, Florida, United States
Northwestern University — Chicago, Illinois, United States
Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
Decatur Memorial Hospital — Decatur, Illinois, United States
University of Kansas Clinical Research Center — Fairway, Kansas, United States
University of Kansas Cancer Center — Kansas City, Kansas, United States
University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic — Metairie, Louisiana, United States
Maine Medical Center-Bramhall Campus — Portland, Maine, United States
Maine Medical Center- Scarborough Campus — Scarborough, Maine, United States
Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
IHA Hematology Oncology Consultants-Brighton — Brighton, Michigan, United States
Saint Joseph Mercy Brighton — Brighton, Michigan, United States
IHA Hematology Oncology Consultants-Canton — Canton, Michigan, United States
Saint Joseph Mercy Canton — Canton, Michigan, United States
IHA Hematology Oncology Consultants-Chelsea — Chelsea, Michigan, United States
Saint Joseph Mercy Chelsea — Chelsea, Michigan, United States
Henry Ford Hospital — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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