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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03757949
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : September 27, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Carcinoma Other: Laboratory Biomarker Analysis Dietary Supplement: Nutritional Intervention Other: Placebo Administration Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Phase III Double Blind Clinical Trial Evaluating the Effect of Immune-Enhancing Nutrition on Radical Cystectomy Outcomes
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : May 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Administration
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Post-operative complications [ Time Frame: Up to 30 days post surgery ]
    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.


Secondary Outcome Measures :
  1. Complications [ Time Frame: Up to 90 days post surgery ]
    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.

  2. Postoperative Infections [ Time Frame: Up to 90 days post surgery ]
    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.

  3. Anthropometrics and body composition [ Time Frame: Baseline to 30 days post surgery ]
    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.

  4. Quality of life [ Time Frame: Up to 30 days post surgery ]
    Functional Assessment of Anorexia/Cachexia Therapy will be completed.

  5. Readmission rates [ Time Frame: Up to 90 days post surgery ]
    Readmission will be defined as admission to any hospital after discharge home until 90 days after surgery. The reason for readmission will be recorded.

  6. 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 ]
    Will be explored using Kaplan Meier curves.

  7. Overall survival [ Time Frame: From date of randomization to date of death due to any cause, assessed up to 2 years ]
    Will be explored using Kaplan Meier curves.

  8. Performance status [ Time Frame: Up to 3 years ]
    Graded according to the Zubrod performance status scale.

  9. Infection rate [ Time Frame: At 30 and 90 days ]
    Will be determined by antibiotic use outside of prophylaxis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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) 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757949


Locations
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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jill M Hamilton-Reeves Southwest Oncology Group
More Information
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT03757949    
Other Study ID Numbers: S1600
NCI-2017-02442 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1600 ( Other Identifier: SWOG )
SWOG-S1600 ( Other Identifier: DCP )
S1600 ( Other Identifier: CTEP )
UG1CA189974 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: September 27, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Urinary Bladder Diseases
Urologic Diseases