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Brief Title: Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes

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

INTRODUCTION

  • Org Study ID: S1600
  • Secondary ID: NCI-2017-02442, S1600, SWOG-S1600, S1600, UG1CA189974
  • NTC ID: NCT03757949
  • Sponsor: Southwest Oncology Group

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.

  • Overall Status
    Recruiting
  • Start Date
    February 21, 2019
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Post-operative complications

Primary Outcome 1 - Timeframe: Up to 30 days post surgery

CONDITION

  • Bladder Carcinoma

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jill M Hamilton-Reeves

Role: Principal Investigator

Affiliation: Southwest Oncology Group

Overall Contact

Name: Jill M Hamilton-Reeves

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-826-4673
becomingapatient@coh.org
Facility: Los Angeles County-USC Medical Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Principal Investigator
Kevin G. Chan
323-865-0451
cancer@northwestern.edu
Facility: USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Site Public Contact
323-865-0451
rhamrick@dmhhs.org
Facility: USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California 92663
United States
Status: Recruiting Contact: Principal Investigator
Siamak Daneshmand
323-865-0451
rhamrick@dmhhs.org
Facility: Keck Medical Center of USC Pasadena
Pasadena, California 91105
United States
Status: Recruiting Contact: Contact
Site Public Contact
323-865-0451
KUCC_Navigation@kumc.edu
Facility: University of Colorado Hospital
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Principal Investigator
Siamak Daneshmand
720-848-0650
KUCC_Navigation@kumc.edu
Facility: Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Status: Recruiting Contact: Contact
Site Public Contact
855-776-0015
KUCC_Navigation@kumc.edu
Facility: Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Principal Investigator
Siamak Daneshmand
312-695-1301
KUCC_Navigation@kumc.edu
Facility: Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4740
emede1@lsuhsc.edu
Facility: Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Principal Investigator
Siamak Daneshmand
217-876-4740
wrighd@mmc.org
Facility: University of Kansas Clinical Research Center
Fairway, Kansas 66205
United States
Status: Recruiting Contact: Contact
Site Public Contact
913-588-3671
stephanie.couch@stjoeshealth.org
Facility: University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Status: Recruiting Contact: Principal Investigator
Janet E. Kukreja
913-588-3671
stephanie.couch@stjoeshealth.org
Facility: University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
United States
Status: Recruiting Contact: Contact
Site Public Contact
913-588-3671
stephanie.couch@stjoeshealth.org
Facility: University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
Status: Recruiting Contact: Principal Investigator
Timothy D. Lyon
913-588-3671
stephanie.couch@stjoeshealth.org
Facility: LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United States
Status: Recruiting Contact: Contact
Site Public Contact
504-210-3539
stephanie.couch@stjoeshealth.org
Facility: Maine Medical Center-Bramhall Campus
Portland, Maine 04102
United States
Status: Recruiting Contact: Principal Investigator
Joshua J. Meeks
207-885-7565
stephanie.couch@stjoeshealth.org
Facility: Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
United States
Status: Recruiting Contact: Contact
Site Public Contact
207-396-8090
stephanie.couch@stjoeshealth.org
Facility: Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
CTOResearch@hfhs.org
Facility: IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Saint Joseph Mercy Brighton
Brighton, Michigan 48114
United States
Status: Recruiting Contact: Principal Investigator
Bryan A. Faller
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Saint Joseph Mercy Canton
Canton, Michigan 48188
United States
Status: Recruiting Contact: Principal Investigator
Jill M. Hamilton-Reeves
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
United States
Status: Recruiting Contact: Principal Investigator
Jill M. Hamilton-Reeves
734-712-3671
CTOResearch@hfhs.org
Facility: Henry Ford Hospital
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-916-3721
stephanie.couch@stjoeshealth.org
Facility: Ascension Saint John Hospital
Detroit, Michigan 48236
United States
Status: Recruiting Contact: Principal Investigator
Jill M. Hamilton-Reeves
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
ou-clinical-trials@ouhsc.edu
Facility: Hurley Medical Center
Flint, Michigan 48503
United States
Status: Recruiting Contact: Principal Investigator
Jill M. Hamilton-Reeves
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
HemonCCTrials@geisinger.edu
Facility: Sparrow Hospital
Lansing, Michigan 48912
United States
Status: Recruiting Contact: Principal Investigator
Jessie R. Gills
734-712-3671
stephanie.couch@stjoeshealth.org
Facility: Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
Status: Recruiting Contact: Contact
Site Public Contact
313-916-3721
stephanie.couch@stjoeshealth.org
Facility: Huron Gastroenterology PC
Ypsilanti, Michigan 48106
United States
Status: Recruiting Contact: Principal Investigator
Matthew H. Hayn
734-712-3671
clinical.research@utmb.edu
Facility: IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
Facility: University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Status: Recruiting Contact: Contact
Site Public Contact
585-275-5830
Facility: University of Rochester
Rochester, New York 14642
United States
Status: Recruiting Contact: Principal Investigator
Philip J. Stella
405-271-8777
Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
Facility: Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
United States
Status: Recruiting Contact: Principal Investigator
Philip J. Stella
570-271-5251
Facility: Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
Facility: Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
United States
Status: Recruiting Contact: Principal Investigator
Philip J. Stella
734-712-3671
Facility: Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
United States
Status: Recruiting Contact: Contact
Site Public Contact
409-772-1950
Facility: University of Texas Medical Branch
Galveston, Texas 77555-0565
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-804-8824
Facility: UTMB Cancer Center at Victory Lakes
League City, Texas 77573
United States
Status: Recruiting Contact: Principal Investigator
Philip J. Stella

Facility: University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Status: Recruiting Contact: Contact
Site Public Contact