Can a special drink cut surgery complications in bladder cancer?

NCT ID NCT03757949

Disease control Sponsor: SWOG Cancer Research Network Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase III trial tests whether an immune-enhancing nutritional supplement, taken before and after bladder cancer removal surgery, can reduce post-operative complications and infections. About 203 participants are randomly assigned to receive either the supplement or a placebo. The goal is to see if better nutrition can boost the immune system and improve recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: immune-enhancing nutritional supplement (SIM)
What this could lead to: If it works, this could show that a simple nutritional drink helps bladder cancer patients recover faster with fewer infections after surgery.
What could go wrong: This is a mid-stage trial with 203 participants, so results may not apply to everyone. The supplement might not reduce complications more than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

203 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder carcinoma

Contacts and locations

Locations

Ascension Saint John Hospital

Detroit, Michigan, 48236, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, 48236, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Hurley Medical Center

Flint, Michigan, 48503, United States
Huron Gastroenterology PC

Ypsilanti, Michigan, 48106, United States
IHA Hematology Oncology Consultants-Ann Arbor

Ypsilanti, Michigan, 48197, United States
IHA Hematology Oncology Consultants-Brighton

Brighton, Michigan, 48114, United States
IHA Hematology Oncology Consultants-Canton

Canton, Michigan, 48188, United States
IHA Hematology Oncology Consultants-Chelsea

Chelsea, Michigan, 48118, United States
Keck Medical Center of USC Pasadena

Pasadena, California, 91105, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006, United States
Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017, United States
Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201, United States
Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States
Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074, United States
Maine Medical Center-Bramhall Campus

Portland, Maine, 04102, United States
Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States
Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States
Northwestern University

Chicago, Illinois, 60611, United States
Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States
Saint Joseph Mercy Brighton

Brighton, Michigan, 48114, United States
Saint Joseph Mercy Canton

Canton, Michigan, 48188, United States
Saint Joseph Mercy Chelsea

Chelsea, Michigan, 48118, United States
Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States
Sparrow Hospital

Lansing, Michigan, 48912, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States
UTMB Cancer Center at Victory Lakes

League City, Texas, 77573, United States
University of Colorado Hospital

Aurora, Colorado, 80045, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States
University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Texas Medical Branch

Galveston, Texas, 77555-0565, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

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