A Study to Evaluate Nutrition Therapy in Improving Immune System in Bladder Cancer Patients

Overview

About this study

The purpose of this study is to evaluate 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Patients must have a tissue diagnosis of primary cell carcinoma of the bladder by TURBT or partial cystectomy. Patients may not have any evidence of unresectable disease or metastatic disease as assessed by exam under anesthesia or imaging (CT, MRI, PET).
  • There must be plans for the cystectomy to be performed within 28 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 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 are not eligible.
  • Patients must be > 18 years of age.
  • 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 dietitian) 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 or their legally authorized representative must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.
  • As a part of the OPEN registration process (see Section 13.3 for OPEN access instructions) 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 because the dietary recall phone interviews will only be conducted in English.

Exclusion Criteria:

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Paul Young, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Tollefson, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20462813

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