Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

200

Study ID:

NCT03757949

Recruitment Status:

Recruiting

Sponsor:

Southwest Oncology Group

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There are 38 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States More Info
Site Public Contact
Contact
800-826-4673
[email protected]
Kevin G. Chan
Principal Investigator
Los Angeles County-USC Medical Center
Los Angeles California, 90033, United States More Info
Site Public Contact
Contact
323-865-0451
Siamak Daneshmand
Principal Investigator
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States More Info
Site Public Contact
Contact
323-865-0451
Siamak Daneshmand
Principal Investigator
USC Norris Oncology/Hematology-Newport Beach
Newport Beach California, 92663, United States More Info
Site Public Contact
Contact
323-865-0451
Siamak Daneshmand
Principal Investigator
Keck Medical Center of USC Pasadena
Pasadena California, 91105, United States More Info
Site Public Contact
Contact
323-865-0451
Siamak Daneshmand
Principal Investigator
University of Colorado Hospital
Aurora Colorado, 80045, United States More Info
Site Public Contact
Contact
720-848-0650
Janet E. Kukreja
Principal Investigator
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States More Info
Site Public Contact
Contact
855-776-0015
Timothy D. Lyon
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Site Public Contact
Contact
312-695-1301
[email protected]
Joshua J. Meeks
Principal Investigator
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4740
[email protected]
Bryan A. Faller
Principal Investigator
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4740
[email protected]
Bryan A. Faller
Principal Investigator
University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Jill M. Hamilton-Reeves
Principal Investigator
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Jill M. Hamilton-Reeves
Principal Investigator
University of Kansas Hospital-Indian Creek Campus
Overland Park Kansas, 66211, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Jill M. Hamilton-Reeves
Principal Investigator
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Jill M. Hamilton-Reeves
Principal Investigator
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie Louisiana, 70006, United States More Info
Site Public Contact
Contact
504-210-3539
[email protected]
Jessie R. Gills
Principal Investigator
Maine Medical Center-Bramhall Campus
Portland Maine, 04102, United States More Info
Site Public Contact
Contact
207-885-7565
Matthew H. Hayn
Principal Investigator
Maine Medical Center- Scarborough Campus
Scarborough Maine, 04074, United States More Info
Site Public Contact
Contact
207-396-8090
[email protected]
Matthew H. Hayn
Principal Investigator
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
IHA Hematology Oncology Consultants-Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Saint Joseph Mercy Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
IHA Hematology Oncology Consultants-Canton
Canton Michigan, 48188, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Saint Joseph Mercy Canton
Canton Michigan, 48188, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
IHA Hematology Oncology Consultants-Chelsea
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Ding Wang
Principal Investigator
Ascension Saint John Hospital
Detroit Michigan, 48236, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Hurley Medical Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods Michigan, 48236, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Sparrow Hospital
Lansing Michigan, 48912, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Henry Ford West Bloomfield Hospital
West Bloomfield Michigan, 48322, United States More Info
Site Public Contact
Contact
313-916-3721
[email protected]
Ding Wang
Principal Investigator
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti Michigan, 48197, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States More Info
Site Public Contact
Contact
601-815-6700
John C. Henegan
Principal Investigator
University of Rochester
Rochester New York, 14642, United States More Info
Site Public Contact
Contact
585-275-5830
Paul M. Barr
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Sanjay G. Patel
Principal Investigator
Lehigh Valley Hospital - Muhlenberg
Bethlehem Pennsylvania, 18017, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Geisinger Medical Center
Danville Pennsylvania, 17822, United States More Info
Site Public Contact
Contact
570-271-5251
[email protected]
Matthew Meissner
Principal Investigator
Pocono Medical Center
East Stroudsburg Pennsylvania, 18301, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Lehigh Valley Hospital-Hazleton
Hazleton Pennsylvania, 18201, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
Philip J. Stella
Principal Investigator
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States More Info
Site Public Contact
Contact
409-772-1950
[email protected]
Stephen B. Williams
Principal Investigator
UTMB Cancer Center at Victory Lakes
League City Texas, 77573, United States More Info
Site Public Contact
Contact
800-917-8906
Stephen B. Williams
Principal Investigator
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
University of Washington Medical Center - Montlake
Seattle Washington, 98195, United States More Info
Site Public Contact
Contact
800-804-8824
Jonathan L. Wright
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

200

Study ID:

NCT03757949

Recruitment Status:

Recruiting

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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