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

Purpose

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.

Condition

  • Bladder Carcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm I (SIM)
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Dietary Supplement: Nutritional Intervention
    Receive SIM PO
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Placebo Comparator
Arm II (placebo)
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Placebo
    Given PO
    Other names:
    • placebo therapy
    • PLCB
    • sham therapy
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555-0565
Contact:
Site Public Contact
409-772-1950
clinical.research@utmb.edu

UTMB Cancer Center at Victory Lakes
League City, Texas 77573
Contact:
Site Public Contact
800-917-8906

More Details

NCT ID
NCT03757949
Status
Recruiting
Sponsor
Southwest Oncology Group

Study Contact

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.