NCT03757949

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Carcinoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIETARY_SUPPLEMENT	Nutritional Intervention	Receive SIM PO
OTHER	Placebo Administration	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-03-05
• Primary completion: 2024-01-01
• Completion: 2027-01-01
• First posted: 2018-11-29
• Last updated: 2025-05-15
• Results posted: 2025-05-15

Locations

46 sites across 1 country: United States