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

NCT ID: NCT03757949

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-05
• Study Completion Date: 2027-01-01

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.

Conditions

Bladder Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Nutritional Intervention

Intervention Type: DIETARY_SUPPLEMENT

Receive SIM PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: PLACEBO_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Placebo Administration

Intervention Type: OTHER

Given PO

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Nutritional Intervention

Receive SIM PO

Intervention Type: DIETARY_SUPPLEMENT

Placebo Administration

Given PO

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jill M Hamilton-Reeves

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2017-02442

Identifier Type: REGISTRY

Identifier Source: secondary_id

S1600

Identifier Type: OTHER

Identifier Source: secondary_id

SWOG-S1600

Identifier Type: OTHER

Identifier Source: secondary_id

S1600

Identifier Type: OTHER

Identifier Source: secondary_id

UG1CA189974

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S1600

Identifier Type: -

Identifier Source: org_study_id