Bladder CancerNCT02050451
Perioperative Oral Nutrition Intervention for Patients Undergoing Radical Cystectomy
A study testing Ensure Plus® and Multivitamin in people with Bladder Cancer, run by Vanderbilt University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Ensure Plus® and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution
Who cannot join
- inability to tolerate oral supplementation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: 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
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.
The 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.
Patients 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.
- Conditions
- Bladder Cancer
- Being tested
- Ensure Plus®, Multivitamin
- Keywords
- radical cystectomy, urinary diversion, nutrition, oral supplementation, enteral nutrition
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ensure Plus®Dietary supplement
Also called Ensure®
MultivitaminDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Intervention | Experimental | Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery Receives: Dietary Supplement: Ensure Plus® |
| Control | Active comparator | Over the counter daily multivitamin for 2 weeks before and 4 weeks after surgery Receives: Dietary Supplement: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-free days (HFDs)
The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups
Measured: 30 days
Secondary outcomes (8)
Serum markers
The investigators will compare serum levels of albumin, prealbumin, transferrin and retinol binding protein and C-reactive protein between groups
Measured: 30 days
Body composition
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
Measured: 30 days
Tolerability / compliance
The investigators will assess the patients' ability to tolerate and comply with the nutrition intervention
Measured: 30 days
Complications
The investigators will compare the difference in rate, type and severity of post-operative complications between groups
Measured: 30 days
Length of stay
The investigators will compare the length of stay following surgery between the two groups
Measured: 30 days
Readmission rate
The investigators will compare the rate of readmissions over the 30 day postoperative period between intervention and control
Measured: 30 days
Mortality
The investigators will compare overall survival between groups over the 30 day postoperative period
Measured: 30 days
Calories
The investigators will compare caloric and nutrient intake between groups using comprehensive dietary assessment tools
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma
- Responsible party
- Principal investigator, Chad Ritch, Vanderbilt University
- Investigators
- Chad R Ritch, MD, Principal investigator, Department of Urologic Surgery, Vanderbilt University Medical CenterMichael S Cookson, MD, Study director, Department of Urology, University of Oklahoma Medical CenterHeidi J Silver, PhD, RD, Study director, Vanderbilt Center for Human NutritionPeter E Clark, MD, Study director, Department of Urologic Surgery, Vanderbilt University Medical CenterSam S Chang, MD, Study director, Department of Urologic Surgery, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02050451
- Sponsor's protocol ID
- VU-IRB-131560
- Status last verified
- Mar 2017
- First submitted
- 28 Jan 2014
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21074802Stimson 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.
PubMed 20723939Morgan 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.
PubMed 21788035
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02050451
- Acronym / sponsor ID
- VU-IRB-131560
- Conditions
- Bladder Cancer
- Keywords
- radical cystectomy, urinary diversion, nutrition, oral supplementation, enteral nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- University of Oklahoma
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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.
Patients 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutrition Intervention | Experimental | Dietary Supplement: Ensure Plus®Ensure Plus®, consumed orally twice daily for 2 weeks before and 4 weeks after surgery |
| Control | Active comparator | Dietary Supplement: MultivitaminOver the counter daily multivitamin for 2 weeks before and 4 weeks after surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients eligible for elective radical cystectomy for bladder cancer at the sponsoring institution
Key exclusion criteria (1 listed)
- inability to tolerate oral supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ensure Plus®Also: Ensure® | Dietary supplement | Nutrition Intervention |
| Multivitamin | Dietary supplement | Control |
Primary outcome
Hospital-free days (HFDs)
Time frame: 30 days
The study is powered to detect a difference in the number of HFDs over a 30 day period between intervention and control groups
8 secondary outcomes
Serum markers
Time frame: 30 days
Body composition
Time frame: 30 days
Tolerability / compliance
Time frame: 30 days
Complications
Time frame: 30 days
Length of stay
Time frame: 30 days
Readmission rate
Time frame: 30 days
Mortality
Time frame: 30 days
Calories
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 21074802Gregg 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.
- Background: PubMed 20723939Stimson 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.
- Background: PubMed 21788035Morgan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chad R Ritch, MD principal investigator
Department of Urologic Surgery, Vanderbilt University Medical Center
Michael S Cookson, MD study director
Department of Urology, University of Oklahoma Medical Center
Heidi J Silver, PhD, RD study director
Vanderbilt Center for Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ensure Plus® and Multivitamin in people with Bladder Cancer, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-free days (HFDs) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02050451, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.