<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03757949</url>
  </required_header>
  <id_info>
    <org_study_id>S1600</org_study_id>
    <secondary_id>NCI-2017-02442</secondary_id>
    <secondary_id>S1600</secondary_id>
    <secondary_id>SWOG-S1600</secondary_id>
    <secondary_id>S1600</secondary_id>
    <secondary_id>UG1CA189974</secondary_id>
    <nct_id>NCT03757949</nct_id>
  </id_info>
  <brief_title>Nutrition Therapy in Improving Immune System in Patients With Bladder Cancer That Can Be Removed by Surgery</brief_title>
  <official_title>A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SWOG Cancer Research Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>SWOG Cancer Research Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial studies how well nutrition therapy works in improving immune system in&#xD;
      patients with bladder cancer that can be removed by surgery. Improving nutrition before and&#xD;
      after surgery may reduce the infections and other problems that sometimes occur after&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To compare the impact of consuming perioperative specialized immune-modulating drinks&#xD;
      (SIM, Impact Advanced Recovery, Nestle) to oral nutrition supplement control drinks (ONS,&#xD;
      Oral Nutrition Control, Nestle) on post-operative complications (any versus [vs.] none)&#xD;
      within 30 days after scheduled radical cystectomy (RC).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To assess whether SIM use compared to ONS reduces late-phase post-operative complications&#xD;
      within 90 days after scheduled RC.&#xD;
&#xD;
      II. To assess whether SIM use compared to ONS reduces infections. III. To assess whether SIM&#xD;
      use compared to ONS reduces skeletal muscle wasting. IV. To assess whether SIM use compared&#xD;
      to ONS reduces high grade post-operative complications.&#xD;
&#xD;
      V. To assess whether SIM use compared to ONS reduces readmission rates. VI. To assess whether&#xD;
      SIM use compared to ONS improves quality of life. VII. To assess whether SIM use compared to&#xD;
      ONS improves disease-free survival after surgery and overall survival.&#xD;
&#xD;
      TERTIARY OBJECTIVES:&#xD;
&#xD;
      I. To assess the impact of SIM use on the expansion of myeloid-derived suppressor cells.&#xD;
&#xD;
      II. To assess the impact of SIM use on pro-inflammatory cytokines and neutrophil: lymphocyte&#xD;
      ratios.&#xD;
&#xD;
      III. To assess the impact of SIM use on post-operative arginine deficiency and amino acid&#xD;
      metabolism.&#xD;
&#xD;
      IV. To explore the association of dietary intake variables (nutrition status, calories,&#xD;
      protein, and immune-enhancing factors) and study outcomes.&#xD;
&#xD;
      TRANSLATIONAL MEDICINE OBJECTIVES:&#xD;
&#xD;
      I. To describe the microbiome of the gut in patients undergoing radical cystectomy and&#xD;
      urinary diversion prior to initiation of immunonutrition or a nutrition control.&#xD;
&#xD;
      II. To define the microbiome change in patients undergoing radical cystectomy and urinary&#xD;
      diversion after they have received blinded immunonutrition or control nutritional supplement.&#xD;
&#xD;
      III. To correlate cancer treatments, postoperative complications (specifically infections)&#xD;
      and nutritional status with microbiome composition.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive SIM orally (PO) thrice daily (TID) on days -5 to -1 and 1-5. Patients&#xD;
      undergo standard of care surgery on day 0.&#xD;
&#xD;
      ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard&#xD;
      of care surgery on day 0.&#xD;
&#xD;
      After completion of study, patients are followed up at 2, 30, and 90 days, and at 6, 9, 12,&#xD;
      18, 24, and 36 months after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>Up to 30 days post surgery</time_frame>
    <description>A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus [vs.] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Up to 90 days post surgery</time_frame>
    <description>Complications will be defined using surgery-specific categories (ileus, deep vein thrombosis, pneumonia, wound infection, urinary tract infection, return to operation room, pulmonary embolus, myocardial infarction, cerebral vascular accident, dehiscence, sepsis, respiratory failure, bowel leak, urine leak, small bowel obstruction, death, or other). Post-operative ileus will be defined as a delay in feeding of greater than or equal to five days post operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Infections</measure>
    <time_frame>Up to 90 days post surgery</time_frame>
    <description>Infectious complications are defined by the need for intervention or prescription of non-prophylactic antibiotics to treat infection. In addition, infections will be categorized by intra-abdominal infection or surgical site infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anthropometrics and body composition</measure>
    <time_frame>Baseline to 30 days post surgery</time_frame>
    <description>Changes in fat mass and non-bone lean tissue (muscle mass) will be assessed by dual-energy X-ray absorptiometry. The fat-free mass index and the appendicular skeletal muscle will be examined over time. Body weight (in a hospital gown without shoes) will be measured using a digital scale accurate to +/- 0.1 kg. Two measurements will be taken and averaged; if the two measurements differ by greater than 0.2 kg, a third measure will be taken. Height will be determined using a wall-mounted stadiometer (+/- 0.1 cm). Two measurements will be taken and averaged; if the two measurements differ by greater than 0.2 cm, a third measure will be taken.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to 30 days post surgery</time_frame>
    <description>Functional Assessment of Anorexia/Cachexia Therapy will be completed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rates</measure>
    <time_frame>Up to 90 days post surgery</time_frame>
    <description>Readmission will be defined as admission to any hospital after discharge home until 90 days after surgery. The reason for readmission will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease free survival</measure>
    <time_frame>From date of randomization to date of first documentation of relapse/recurrence or death due to any cause, assessed up to 2 years</time_frame>
    <description>Will be explored using Kaplan Meier curves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of randomization to date of death due to any cause, assessed up to 2 years</time_frame>
    <description>Will be explored using Kaplan Meier curves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance status</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Graded according to the Zubrod performance status scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection rate</measure>
    <time_frame>At 30 and 90 days</time_frame>
    <description>Will be determined by antibiotic use outside of prophylaxis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Bladder Carcinoma</condition>
  <arm_group>
    <arm_group_label>Arm I (SIM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (SIM)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional Intervention</intervention_name>
    <description>Receive SIM PO</description>
    <arm_group_label>Arm I (SIM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo Administration</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (SIM)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (SIM)</arm_group_label>
    <arm_group_label>Arm II (placebo)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have a tissue diagnosis of primary cell carcinoma of the bladder by&#xD;
             transurethral resection of bladder tumor (TURBT) or partial cystectomy; patients may&#xD;
             not have any evidence of unresectable disease or metastatic disease as assessed by&#xD;
             exam under anesthesia or imaging (computed tomography [CT], magnetic resonance imaging&#xD;
             [MRI], positron-emission tomography [PET])&#xD;
&#xD;
          -  There must be plans for the cystectomy to be performed within 28 calendar days after&#xD;
             registration&#xD;
&#xD;
          -  Surgery must be planned to be performed under pre-approved, study-specific surgical&#xD;
             guidelines&#xD;
&#xD;
          -  Patients must have completed any neoadjuvant chemotherapy or immunotherapy&#xD;
             (intravesical or systemic) &gt;= 14 calendar days prior to registration and any&#xD;
             toxicities resolved to at least grade 2&#xD;
&#xD;
          -  Patients may have a history of radiation therapy; radiation therapy must have been&#xD;
             completed &gt;= 180 days prior to registration&#xD;
&#xD;
          -  Patients may have a history of prior partial cystectomy; prior partial cystectomy must&#xD;
             have been completed at least 180 days prior to registration&#xD;
&#xD;
          -  Patients with planned adjuvant chemotherapy within 90 days after radical cystectomy&#xD;
             will not be eligible&#xD;
&#xD;
          -  Patients must be able to swallow liquid and have no refractory nausea, vomiting,&#xD;
             malabsorption, or significant small bowel resection that would preclude adequate&#xD;
             absorption; patients on tube feeding are not eligible&#xD;
&#xD;
          -  Patients must have their baseline nutrition status assessed using the Scored&#xD;
             Patient-Generated Subjective Global Assessment (PG-SGA) by a clinician or licensed&#xD;
             healthcare practitioner (trained physician, nurse, or dietician) within 14 days prior&#xD;
             to registration and must not have a global category rating of stage C (severely&#xD;
             malnourished)&#xD;
&#xD;
          -  Patients must not have galactosemia&#xD;
&#xD;
          -  Patients must not have known active viral infections such as human immunodeficiency&#xD;
             virus (HIV) or hepatitis, as these chronic viral infections may cause cachexia and&#xD;
             immunodeficiency and thus alter the biology regarding the study endpoints&#xD;
&#xD;
          -  No other prior malignancy is allowed except for the following: adequately treated&#xD;
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated&#xD;
             stage I or II cancer from which the patient is currently in complete remission, or any&#xD;
             other cancer from which the patient has been disease free for two years; prostate&#xD;
             cancer found at cystectomy would not be considered a prior malignancy&#xD;
&#xD;
          -  Patients must not be pregnant or nursing as the conditions preclude candidacy for&#xD;
             radical cystectomy&#xD;
&#xD;
          -  Patients must consent and be willing to have specimens collected and submitted&#xD;
&#xD;
          -  Patients must be offered the opportunity to participate in additional specimen banking&#xD;
&#xD;
          -  Patients or their legally authorized representative must be informed of the&#xD;
             investigational nature of this study and must sign and give written informed consent&#xD;
             in accordance with institutional and federal guidelines&#xD;
&#xD;
          -  As a part of the Oncology Patient Enrollment Network (OPEN) registration process the&#xD;
             treating institution's identity is provided in order to ensure that the current&#xD;
             (within 365 days) date of institutional review board approval for this study has been&#xD;
             entered in the system&#xD;
&#xD;
          -  Patients must consent and provide their telephone contact information for four 24-hour&#xD;
             dietary recall phone interviews to be conducted by staff at the Exercise, Diet,&#xD;
             Genitourinary, &amp; Endocrinology Laboratory (EDGE) Research Laboratory&#xD;
&#xD;
          -  Patients must be able to understand and speak English and/or Spanish because the&#xD;
             dietary recall phone interviews will only be conducted in English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jill M Hamilton-Reeves</last_name>
    <role>Principal Investigator</role>
    <affiliation>SWOG Cancer Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-826-4673</phone>
      <email>becomingapatient@coh.org</email>
    </contact>
    <investigator>
      <last_name>Kevin G. Chan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Los Angeles County-USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>323-865-0451</phone>
    </contact>
    <investigator>
      <last_name>Siamak Daneshmand</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>323-865-0451</phone>
    </contact>
    <investigator>
      <last_name>Siamak Daneshmand</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>USC Norris Oncology/Hematology-Newport Beach</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>323-865-0451</phone>
    </contact>
    <investigator>
      <last_name>Siamak Daneshmand</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Keck Medical Center of USC Pasadena</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>323-865-0451</phone>
    </contact>
    <investigator>
      <last_name>Siamak Daneshmand</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>720-848-0650</phone>
    </contact>
    <investigator>
      <last_name>Janet E. Kukreja</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>855-776-0015</phone>
    </contact>
    <investigator>
      <last_name>Timothy D. Lyon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>312-695-1301</phone>
      <email>cancer@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Joshua J. Meeks</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Care Specialists of Illinois - Decatur</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-876-4740</phone>
      <email>rhamrick@dmhhs.org</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-876-4740</phone>
      <email>rhamrick@dmhhs.org</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Clinical Research Center</name>
      <address>
        <city>Fairway</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Jill M. Hamilton-Reeves</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Jill M. Hamilton-Reeves</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Hospital-Indian Creek Campus</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Jill M. Hamilton-Reeves</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Kansas Hospital-Westwood Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-588-3671</phone>
      <email>KUCC_Navigation@kumc.edu</email>
    </contact>
    <investigator>
      <last_name>Jill M. Hamilton-Reeves</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>LSU Healthcare Network / Metairie Multi-Specialty Clinic</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>504-210-3539</phone>
      <email>emede1@lsuhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Jessie R. Gills</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center-Bramhall Campus</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-885-7565</phone>
    </contact>
    <investigator>
      <last_name>Matthew H. Hayn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center- Scarborough Campus</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-396-8090</phone>
      <email>wrighd@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Matthew H. Hayn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Brighton</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Brighton</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48188</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48188</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Chelsea</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Chelsea</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>313-916-3721</phone>
      <email>CTOResearch@hfhs.org</email>
    </contact>
    <investigator>
      <last_name>Ding Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension Saint John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Genesys Hurley Cancer Institute</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hurley Medical Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Van Elslander Cancer Center</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sparrow Hospital</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Henry Ford West Bloomfield Hospital</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>313-916-3721</phone>
      <email>CTOResearch@hfhs.org</email>
    </contact>
    <investigator>
      <last_name>Ding Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huron Gastroenterology PC</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IHA Hematology Oncology Consultants-Ann Arbor</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>601-815-6700</phone>
    </contact>
    <investigator>
      <last_name>John C. Henegan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>585-275-5830</phone>
    </contact>
    <investigator>
      <last_name>Paul M. Barr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>405-271-8777</phone>
      <email>ou-clinical-trials@ouhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Sanjay G. Patel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital - Muhlenberg</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>570-271-5251</phone>
      <email>HemonCCTrials@geisinger.edu</email>
    </contact>
    <investigator>
      <last_name>Matthew Meissner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pocono Medical Center</name>
      <address>
        <city>East Stroudsburg</city>
        <state>Pennsylvania</state>
        <zip>18301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Hazleton</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <zip>18201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Philip J. Stella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555-0565</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>409-772-1950</phone>
      <email>clinical.research@utmb.edu</email>
    </contact>
    <investigator>
      <last_name>Stephen B. Williams</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UTMB Cancer Center at Victory Lakes</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-917-8906</phone>
    </contact>
    <investigator>
      <last_name>Stephen B. Williams</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute/University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center - Montlake</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-804-8824</phone>
    </contact>
    <investigator>
      <last_name>Jonathan L. Wright</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>October 1, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03757949
org study id: S1600
secondary id: NCI-2017-02442
secondary id: S1600
secondary id: SWOG-S1600
secondary id: S1600
secondary id: UG1CA189974
nct id: NCT03757949
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
PRIMARY OBJECTIVE:

      I. To compare the impact of consuming perioperative specialized immune-modulating 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 after surgery 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.

      TRANSLATIONAL MEDICINE OBJECTIVES:

      I. To describe the microbiome of the gut in patients undergoing radical cystectomy and
      urinary diversion prior to initiation of immunonutrition or a nutrition control.

      II. To define the microbiome change in patients undergoing radical cystectomy and urinary
      diversion after they have received blinded immunonutrition or control nutritional supplement.

      III. To correlate cancer treatments, postoperative complications (specifically infections)
      and nutritional status with microbiome composition.

      OUTLINE: Patients are randomized to 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Post-operative complications
time frame: Up to 30 days post surgery
description: A post-operative complication is defined as a binary indicator variable indicating whether the patient experienced any complication (any/none; Clavien-Dindo grades I-V). The primary analysis will be based on a multivariable logistic regression under intent-totreat among all randomized patients, irrespective of their eligibility status, adjusting for the specified stratification factors: a. Diversion type (neobladder versus [vs.] ileal conduit); b. Prior neoadjuvant chemotherapy (any vs. none); and c. Nutrition status (well nourished vs. moderate malnutrition). A Fisher's exact test will also be conducted to establish whether the results are sensitive to model assumptions. A single interim analysis for efficacy will be conducted when 50% of patients achieve their endpoint at the alpha=0.005 level. Accordingly, the final analysis will be conducted at the alpha=0.045 level. A separate analysis among all eligible randomized patients will also be conducted.
measure: Complications
time frame: Up to 90 days post surgery
description: Complications will be defined using surgery-specific categories (ileus, deep vein thrombosis, pneumonia, wound infection, urinary tract infection, return to operation room, pulmonary embolus, myocardial infarction, cerebral vascular accident, dehiscence, sepsis, respiratory failure, bowel leak, urine leak, small bowel obstruction, death, or other). Post-operative ileus will be defined as a delay in feeding of greater than or equal to five days post operatively.
measure: Postoperative Infections
time frame: Up to 90 days post surgery
description: Infectious complications are defined by the need for intervention or prescription of non-prophylactic antibiotics to treat infection. In addition, infections will be categorized by intra-abdominal infection or surgical site infection.
measure: Anthropometrics and body composition
time frame: Baseline to 30 days post surgery
description: Changes in fat mass and non-bone lean tissue (muscle mass) will be assessed by dual-energy X-ray absorptiometry. The fat-free mass index and the appendicular skeletal muscle will be examined over time. Body weight (in a hospital gown without shoes) will be measured using a digital scale accurate to +/- 0.1 kg. Two measurements will be taken and averaged; if the two measurements differ by greater than 0.2 kg, a third measure will be taken. Height will be determined using a wall-mounted stadiometer (+/- 0.1 cm). Two measurements will be taken and averaged; if the two measurements differ by greater than 0.2 cm, a third measure will be taken.
measure: Quality of life
time frame: Up to 30 days post surgery
description: Functional Assessment of Anorexia/Cachexia Therapy will be completed.
measure: Readmission rates
time frame: Up to 90 days post surgery
description: Readmission will be defined as admission to any hospital after discharge home until 90 days after surgery. The reason for readmission will be recorded.
measure: Disease free survival
time frame: From date of randomization to date of first documentation of relapse/recurrence or death due to any cause, assessed up to 2 years
description: Will be explored using Kaplan Meier curves.
measure: Overall survival
time frame: From date of randomization to date of death due to any cause, assessed up to 2 years
description: Will be explored using Kaplan Meier curves.
measure: Performance status
time frame: Up to 3 years
description: Graded according to the Zubrod performance status scale.
measure: Infection rate
time frame: At 30 and 90 days
description: Will be determined by antibiotic use outside of prophylaxis.
arm group label: Arm I (SIM)
arm group type: Experimental
description: Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
arm group label: Arm II (placebo)
arm group type: Placebo Comparator
description: ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm I (SIM)
arm group label: Arm II (placebo)
intervention type: Dietary Supplement
intervention name: Nutritional Intervention
description: Receive SIM PO
arm group label: Arm I (SIM)
intervention type: Other
intervention name: Placebo Administration
description: Given PO
arm group label: Arm II (placebo)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (SIM)
arm group label: Arm II (placebo)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (SIM)
arm group label: Arm II (placebo)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jill M Hamilton-Reeves
role: Principal Investigator
affiliation: SWOG Cancer Research Network
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country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms