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

NCT03757949 | Active Not Recruiting Phase 3 Results DMC

• 4 other identifiers: S1600NCI-2017-02442SWOG-S1600UG1CA189974
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 46

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.

Conditions

Bladder Carcinoma

Outcome Measures

Primary Outcomes (1)

• Post-operative Complications (30 Days)

  A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus \[vs.\] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.

  Up to 30 days post surgery

Secondary Outcomes (7)

• Post-Op Complications (90 Days)

  Within 90 days after scheduled RC

• Infections

  30 days post-op

• Skeletal Muscle Wasting

  30 days post op

• High Grade Post-Op Complications

  30 days post-op

• Readmission Rates

  30 days post-op

Study Arms (2)

Arm I (SIM)

EXPERIMENTAL

Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.

Other: Laboratory Biomarker Analysis; Dietary Supplement: Nutritional Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (placebo)

PLACEBO COMPARATOR

ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.

Other: Laboratory Biomarker Analysis; Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (SIM); Arm II (placebo)

Nutritional Intervention DIETARY_SUPPLEMENT

Receive SIM PO

Arm I (SIM)

Placebo Administration OTHER

Given PO

Arm II (placebo)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (SIM); Arm II (placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (SIM); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (46)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

Location

Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States

Location

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

Location

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States

Location

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States

Location

Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, 48114, United States

Location

Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States

Location

IHA Hematology Oncology Consultants-Canton

Canton, Michigan, 48188, United States

Location

Saint Joseph Mercy Canton

Canton, Michigan, 48188, United States

Location

IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, 48118, United States

Location

Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, 48236, United States

Location

Sparrow Hospital

Lansing, Michigan, 48912, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States

Location

IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, 48197, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States

Location

UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States

Location

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Danika Lew
• Organization: SWOG

dlew@fredhutch.org

206-667-2272

Study Officials

• Jill M Hamilton-Reeves

  SWOG Cancer Research Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: November 29, 2018
• Study Start: March 5, 2019
• Primary Completion: January 1, 2024
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 4, 2026
• Results First Posted: May 15, 2025

Record last verified: 2026-03

Locations

US (46)