Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-20 @ 10:12 PM
Study NCT ID:
NCT02050451
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2014-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C029401', 'term': 'Ensure Plus'}, {'id': 'C067316', 'term': 'Geritol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-01-28', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital-free days (HFDs)', 'timeFrame': '30 days', 'description': 'The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups'}], 'secondaryOutcomes': [{'measure': 'Serum markers', 'timeFrame': '30 days', 'description': 'The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups'}, {'measure': 'Body composition', 'timeFrame': '30 days', 'description': 'The investigators will measure difference in lean body mass and fat mass between intervention and controls using whole body dual energy X-ray absorptiometry (DEXA) scan'}, {'measure': 'Tolerability / compliance', 'timeFrame': '30 days', 'description': "The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention"}, {'measure': 'Complications', 'timeFrame': '30 days', 'description': 'The investigators will compare the difference in rate, type and severity of post-operative complications between groups'}, {'measure': 'Length of stay', 'timeFrame': '30 days', 'description': 'The investigators will compare the length of stay following surgery between the two groups'}, {'measure': 'Readmission rate', 'timeFrame': '30 days', 'description': 'The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'The investigators will compare overall survival between groups over the 30 day postoperative period'}, {'measure': 'Calories', 'timeFrame': '30 days', 'description': 'The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['radical cystectomy', 'urinary diversion', 'nutrition', 'oral supplementation', 'enteral nutrition'], 'conditions': ['Bladder Cancer']}, 'referencesModule': {'references': [{'pmid': '21074802', 'type': 'BACKGROUND', 'citation': 'Gregg JR, Cookson MS, Phillips S, Salem S, Chang SS, Clark PE, Davis R, Stimson CJ Jr, Aghazadeh M, Smith JA Jr, Barocas DA. Effect of preoperative nutritional deficiency on mortality after radical cystectomy for bladder cancer. J Urol. 2011 Jan;185(1):90-6. doi: 10.1016/j.juro.2010.09.021. Epub 2010 Nov 12.'}, {'pmid': '20723939', 'type': 'BACKGROUND', 'citation': 'Stimson CJ, Chang SS, Barocas DA, Humphrey JE, Patel SG, Clark PE, Smith JA Jr, Cookson MS. Early and late perioperative outcomes following radical cystectomy: 90-day readmissions, morbidity and mortality in a contemporary series. J Urol. 2010 Oct;184(4):1296-300. doi: 10.1016/j.juro.2010.06.007. Epub 2010 Aug 17.'}, {'pmid': '21788035', 'type': 'BACKGROUND', 'citation': 'Morgan TM, Keegan KA, Barocas DA, Ruhotina N, Phillips SE, Chang SS, Penson DF, Clark PE, Smith JA Jr, Cookson MS. Predicting the probability of 90-day survival of elderly patients with bladder cancer treated with radical cystectomy. J Urol. 2011 Sep;186(3):829-34. doi: 10.1016/j.juro.2011.04.089. Epub 2011 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'The current study is designed to assess the impact of an enriched oral nutritional shake (Ensure Plus®) to improve the nutritional status and patient outcome after surgery to remove a cancerous bladder (radical cystectomy). Radical cystectomy with urinary diversion using a segment of intestine is the standard of care for invasive bladder cancer. This operation has a high complication rate and several studies have shown that this may be directly related to poor nutrition.\n\nThe investigators believe that patients who consume an enriched nutritional shake before and after surgery will improve their nutrition status and experience fewer complications, shorter length of stay and less readmissions compared to those who do not.\n\nPatients who are scheduled to undergo elective radical cystectomy will be eligible for enrollment. Once enrolled, they will be randomly assigned to one of two groups. One group will be offered Ensure Plus® twice daily for 2 weeks before and 4 weeks after their surgery and the other will be offered a daily over-the-counter multivitamin for the same period of time. The investigators will follow both groups for up to 30 days after their surgery and compare clinical outcomes such as: complication rates, length of stay, readmission rates and mortality as well as measure serum markers of nutrition status and assess changes in body composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution\n\nExclusion Criteria:\n\n* inability to tolerate oral supplementation'}, 'identificationModule': {'nctId': 'NCT02050451', 'briefTitle': 'Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'A Pilot Study of Perioperative Oral Nutrition Supplementation to Improve Nutritional Status, Post-operative Complications, Length of Stay and Readmission Rates in Patients Undergoing Radical Cystectomy', 'orgStudyIdInfo': {'id': 'VU-IRB-131560'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutrition Intervention', 'description': 'Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery', 'interventionNames': ['Dietary Supplement: Ensure Plus®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery', 'interventionNames': ['Dietary Supplement: Multivitamin']}], 'interventions': [{'name': 'Ensure Plus®', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Ensure®'], 'armGroupLabels': ['Nutrition Intervention']}, {'name': 'Multivitamin', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Chad R Ritch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urologic Surgery, Vanderbilt University Medical Center'}, {'name': 'Michael S Cookson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Urology, University of Oklahoma Medical Center'}, {'name': 'Heidi J Silver, PhD, RD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt Center for Human Nutrition'}, {'name': 'Peter E Clark, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Urologic Surgery, Vanderbilt University Medical Center'}, {'name': 'Sam S Chang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Urologic Surgery, Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oklahoma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Instructor', 'investigatorFullName': 'Chad Ritch', 'investigatorAffiliation': 'Vanderbilt University'}}}}