AzTrials
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Bladder CarcinomaPhase 3NCT03757949

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

A Phase 3 study testing Laboratory Biomarker Analysis, Nutritional Intervention and Quality-of-Life Assessment in people with Bladder Carcinoma, run by SWOG Cancer Research Network at 46 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Carcinoma
What is being tested?
Laboratory Biomarker Analysis, Nutritional Intervention and Quality-of-Life Assessment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
203 participants
Where
46 sitesUnited States
Study dates
5 Mar 2019to 1 Jan 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

46 sites in 1 country.

46 sites in 1 country

United States46 sites

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • IHA Hematology Oncology Consultants-Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • IHA Hematology Oncology Consultants-Canton

    Canton, Michigan, 48188

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • IHA Hematology Oncology Consultants-Chelsea

    Chelsea, Michigan, 48118

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0565

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • UTMB Cancer Center at Victory Lakes

    League City, Texas, 77573

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    Metairie, Louisiana, 70006

  • USC Norris Oncology/Hematology-Newport Beach

    Newport Beach, California, 92663

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Kansas Hospital-Indian Creek Campus

    Overland Park, Kansas, 66211

  • Keck Medical Center of USC Pasadena

    Pasadena, California, 91105

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • Maine Medical Center- Scarborough Campus

    Scarborough, Maine, 04074

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

  • Huron Gastroenterology PC

    Ypsilanti, Michigan, 48106

  • IHA Hematology Oncology Consultants-Ann Arbor

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

  1. 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:

  1. 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:

  1. 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.

Being tested
Laboratory Biomarker Analysis, Nutritional Intervention, Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Nutritional InterventionDietary supplement

    Receive SIM PO

  • Placebo AdministrationOther

    Given PO

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03757949
Study groupRoleWhat they receive
Arm I (SIM)ExperimentalPatients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Receives: Other: Laboratory Biomarker Analysis; Dietary Supplement: Nutritional Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (placebo)Placebo comparatorARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Receives: Other: Laboratory Biomarker Analysis; Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 30 days post surgery

Secondary outcomes (7)

  1. Post-Op Complications (90 Days)

    Late-phase post-operative complications within 90 days after scheduled RC

    Measured: Within 90 days after scheduled RC

  2. Infections

    Number of post-operative infections

    Measured: 30 days post-op

  3. Skeletal Muscle Wasting

    Measured: 30 days post op

  4. High Grade Post-Op Complications

    High grade complications 30 days post-op, where high grade is Clavien-Dindo scores III-V

    Measured: 30 days post-op

  5. Readmission Rates

    Count of participants that were readmitted to hospital within 30 days post-op.

    Measured: 30 days post-op

  6. Quality of Life

    Measured: 30 days post op

  7. 2-Year Disease Free Survival

    Disease free survival is defined as time from surgery to documented recurrence or death from any cause.

    The number reported is the number of participants who survived two years without documented recurrence.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2018
  2. Study start5 Mar 2019
  3. Primary completion1 Jan 2024
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
203 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03757949
Sponsor's protocol ID
S1600
Other IDs
NCI-2017-02442, S1600, SWOG-S1600, S1600, UG1CA189974
Status last verified
Mar 2026
First submitted
1 Oct 2018
Last updated
4 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hamilton-Reeves JM, Unger JM, Holzbeierlein JM, Lew DL, Mark JR, Daneshmand S, Lerner SP, Kukreja JEB, Lee EK, Tabayoyong WB, Hershman DL, Fisch MJ, Henry NL. Immune-Enhancing Nutrition and Outcomes After Radical Cystectomy: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2623622. doi: 10.1001/jamanetworkopen.2026.23622.

    PubMed 42475098

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Laboratory Biomarker Analysis, Nutritional Intervention and Quality-of-Life Assessment in people with Bladder Carcinoma, run by SWOG Cancer Research Network at 46 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative Complications (30 Days) (time frame: Up to 30 days post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03757949, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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