Spots Global Cancer Trial Database for Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery
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Trial Identification
Brief Title: Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery
Official Title: A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Study ID: NCT03757949
Conditions
Study Description
Brief 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.
Detailed Description: PRIMARY OBJECTIVE: I. To compare the impact of consuming perioperative specialized immune-modulating drinks (SIM, Impact Advanced Recovery, Nestle) to oral nutrition supplement control drinks (ONS, Oral Nutrition Control, Nestle) on post-operative complications (any versus \[vs.\] none) within 30 days after scheduled radical cystectomy (RC). SECONDARY OBJECTIVES: I. To assess whether SIM use compared to ONS reduces late-phase post-operative complications within 90 days after scheduled RC. II. To assess whether SIM use compared to ONS reduces infections. III. To assess whether SIM use compared to ONS reduces skeletal muscle wasting. IV. To assess whether SIM use compared to ONS reduces high grade post-operative complications. V. To assess whether SIM use compared to ONS reduces readmission rates. VI. To assess whether SIM use compared to ONS improves quality of life. VII. To assess whether SIM use compared to ONS improves disease-free survival after surgery and overall survival. TERTIARY OBJECTIVES: I. To assess the impact of SIM use on the expansion of myeloid-derived suppressor cells. II. To assess the impact of SIM use on pro-inflammatory cytokines and neutrophil: lymphocyte ratios. III. To assess the impact of SIM use on post-operative arginine deficiency and amino acid metabolism. IV. To explore the association of dietary intake variables (nutrition status, calories, protein, and immune-enhancing factors) and study outcomes. TRANSLATIONAL MEDICINE OBJECTIVES: I. To describe the microbiome of the gut in patients undergoing radical cystectomy and urinary diversion prior to initiation of immunonutrition or a nutrition control. II. To define the microbiome change in patients undergoing radical cystectomy and urinary diversion after they have received blinded immunonutrition or control nutritional supplement. III. To correlate cancer treatments, postoperative complications (specifically infections) and nutritional status with microbiome composition. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive SIM orally (PO) thrice daily (TID) on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0. After completion of study, patients are followed up at 2, 30, and 90 days, and at 6, 9, 12, 18, 24, and 36 months after surgery.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Ascension Saint John Hospital, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center, Grosse Pointe Woods, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
Henry Ford West Bloomfield Hospital, West Bloomfield, Michigan, United States
Huron Gastroenterology PC, Ypsilanti, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor, Ypsilanti, Michigan, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
University of Rochester, Rochester, New York, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital - Muhlenberg, Bethlehem, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Pocono Medical Center, East Stroudsburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton, Hazleton, Pennsylvania, United States
University of Texas Medical Branch, Galveston, Texas, United States
UTMB Cancer Center at Victory Lakes, League City, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Contact Details
Name: Jill M Hamilton-Reeves
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR
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