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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


  • Org Study ID: S1600
  • Secondary ID: NCI-2017-02442,S1600,SWOG-S1600,SWOG-S1600,UG1CA189974
  • NCT ID: NCT03757949
  • NCT Alias:
  • Sponsor: Southwest Oncology Group - Other
  • Source: Southwest Oncology Group

Brief Summary

This randomized 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 OBJECTIVES:

I. To compare the impact of consuming perioperative specialized immunemodulating 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 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.

OUTLINE: Patients are randomized into 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.

Overal Status Start Date Phase Study Type
Recruiting February 21, 2019 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Post-operative complications

Primary Outcome 1 - Time Frame: Up to 30 days post surgery

Condition:

  • Bladder Carcinoma

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) 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

- 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 informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines

- Patients must consent and provide their telephone contact information for two 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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jill Hamilton-Reeves

Role: Principal Investigator

Affiliation: Southwest Oncology Group

Locations

Facility Status Contact
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
Recruiting Site Public Contact
800-826-4673
becomingapatient@coh.org
University of Colorado Hospital
Aurora, Colorado 80045
United States
Recruiting Site Public Contact
720-848-0650
Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
United States
Recruiting Site Public Contact
855-776-0015
Northwestern University
Chicago, Illinois 60611
United States
Recruiting Site Public Contact
312-695-1301
cancer@northwestern.edu
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Recruiting Site Public Contact
217-876-4740
rhamrick@dmhhs.org
University of Kansas Clinical Research Center
Fairway, Kansas 66205
United States
Recruiting Site Public Contact
913-945-7552
ctnursenav@kumc.edu
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
Recruiting Site Public Contact
913-945-7552
ctnursenav@kumc.edu
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
United States
Recruiting Site Public Contact
913-945-7552
ctnursenav@kumc.edu
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
Recruiting Site Public Contact
913-945-7552
ctnursenav@kumc.edu
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana 70006
United States
Recruiting Site Public Contact
504-210-3539
emede1@lsuhsc.edu
Maine Medical Center-Bramhall Campus
Portland, Maine 04102
United States
Recruiting Site Public Contact
207-885-7565
Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
United States
Recruiting Site Public Contact
207-396-8090
wrighd@mmc.org
Mayo Clinic
Rochester, Minnesota 55905
United States
Recruiting Site Public Contact
855-776-0015
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Recruiting Site Public Contact
601-815-6700
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Recruiting Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Recruiting Site Public Contact
215-955-6084
University of Texas Medical Branch
Galveston, Texas 77555-0565
United States
Recruiting Site Public Contact
409-772-1950
clinical.research@utmb.edu
UTMB Cancer Center at Victory Lakes
League City, Texas 77573
United States
Recruiting Site Public Contact
800-917-8906
University of Washington Medical Center
Seattle, Washington 98195
United States
Recruiting Site Public Contact
800-804-8824