Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed … (NCT03757949) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery
United States203 participantsStarted 2019-03-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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-Generate…