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

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: SWOG Cancer Research Network

Overall Contact

Name: Jill M Hamilton-Reeves

Phone: N/A

Email: N/A

LOCATION