A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

Who is this study for? Adult patients with Bladder Carcinoma that have undergone transurethral resection of bladder tumor or partial cystectomy
What treatments are being studied? Dietary Supplement
Status: Active_not_recruiting
Location: See all (46) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
City of Hope Comprehensive Cancer Center
Duarte
Los Angeles County-USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
USC Norris Oncology/Hematology-Newport Beach
Newport Beach
Keck Medical Center of USC Pasadena
Pasadena
Colorado
University of Colorado Hospital
Aurora
Florida
Mayo Clinic in Florida
Jacksonville
Illinois
Northwestern University
Chicago
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Kansas
University of Kansas Clinical Research Center
Fairway
University of Kansas Cancer Center
Kansas City
University of Kansas Hospital-Indian Creek Campus
Overland Park
University of Kansas Hospital-Westwood Cancer Center
Westwood
Louisiana
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie
Maine
Maine Medical Center-Bramhall Campus
Portland
Maine Medical Center- Scarborough Campus
Scarborough
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
IHA Hematology Oncology Consultants-Brighton
Brighton
Saint Joseph Mercy Brighton
Brighton
IHA Hematology Oncology Consultants-Canton
Canton
Saint Joseph Mercy Canton
Canton
IHA Hematology Oncology Consultants-Chelsea
Chelsea
Saint Joseph Mercy Chelsea
Chelsea
Ascension Saint John Hospital
Detroit
Henry Ford Hospital
Detroit
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods
Sparrow Hospital
Lansing
Henry Ford West Bloomfield Hospital
West Bloomfield
Huron Gastroenterology PC
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti
Minnesota
Mayo Clinic in Rochester
Rochester
Mississippi
University of Mississippi Medical Center
Jackson
New York
University of Rochester
Rochester
Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City
Pennsylvania
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Geisinger Medical Center
Danville
Pocono Medical Center
East Stroudsburg
Lehigh Valley Hospital-Hazleton
Hazleton
Texas
University of Texas Medical Branch
Galveston
UTMB Cancer Center at Victory Lakes
League City
Utah
Huntsman Cancer Institute/University of Utah
Salt Lake City
Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond
Washington
University of Washington Medical Center - Montlake
Seattle
Time Frame
Start Date: 2019-03-05
Completion Date: 2027-01-01
Participants
Target number of participants: 203
Treatments
Experimental: Arm I (SIM)
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Placebo_comparator: Arm II (placebo)
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Related Therapeutic Areas
Sponsors
Leads: SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov