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Nutrition Therapy for Bladder Cancer
Phase 3
Waitlist Available
Led By Jill M Hamilton-Reeves
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 not be pregnant or nursing as the conditions preclude candidacy for radical cystectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial studies how well nutrition therapy works in improving immune system in patients with bladder cancer that can be removed by surgery.
Who is the study for?
This trial is for bladder cancer patients who can undergo surgery, have finished any prior chemotherapy or immunotherapy at least 14 days before, and resolved most side effects. They shouldn't be pregnant, nursing, or planning adjuvant chemotherapy soon after surgery. Participants must not have severe malnutrition or active viral infections like HIV/hepatitis and should be able to swallow liquids.Check my eligibility
What is being tested?
The study tests if nutrition therapy improves the immune system in bladder cancer patients around the time of their surgery. It aims to see if better nutrition reduces post-surgery complications. Patients will receive either nutritional intervention or a placebo and complete quality-of-life questionnaires.See study design
What are the potential side effects?
Since this trial focuses on nutrition therapy rather than medication, side effects may include gastrointestinal discomfort from dietary changes. However, specific side effects will depend on individual reactions to the nutritional intervention.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can swallow liquids and don't have issues that affect my nutrient absorption.
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I am not pregnant or nursing.
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I finished my chemotherapy or immunotherapy at least 14 days ago and any side effects have mostly gone away.
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I am not scheduled for chemotherapy within 3 months after bladder removal surgery.
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I do not have active HIV or hepatitis infections.
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My nutrition status was checked recently and I am not severely malnourished.
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My surgery will follow specific guidelines approved for this study.
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I do not have galactosemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative complications
Secondary outcome measures
Anthropometrics and body composition
Complications
Disease free survival
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (SIM)Experimental Treatment4 Interventions
Patients receive SIM PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Group II: Arm II (placebo)Placebo Group4 Interventions
ARM II: Patients receive placebo PO TID on days -5 to -1 and 1-5. Patients undergo standard of care surgery on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nutritional Intervention
2011
Completed Phase 3
~690
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,608 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
264,967 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,168 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before, but it was either skin cancer, early-stage cancer in remission, or any cancer I've been free from for 2 years.I can swallow liquids and don't have issues that affect my nutrient absorption.I am not pregnant or nursing.I finished my chemotherapy or immunotherapy at least 14 days ago and any side effects have mostly gone away.I had partial bladder surgery over 6 months ago.I am not scheduled for chemotherapy within 3 months after bladder removal surgery.I do not have active HIV or hepatitis infections.My nutrition status was checked recently and I am not severely malnourished.My surgery to remove the bladder is scheduled within 4 weeks after signing up.My surgery will follow specific guidelines approved for this study.I can communicate in English or Spanish for dietary interviews.My bladder cancer was confirmed by surgery and has not spread.I finished my radiation therapy more than 6 months ago.I do not have galactosemia.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (SIM)
- Group 2: Arm II (placebo)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the risks of Nutritional Intervention for patients?
"There is some evidence of efficacy and multiple rounds of data supporting safety, so we have given Nutritional Intervention a score of 3."
Answered by AI
Are new patients able to join this research project?
"That is correct, the online listing for this clinical trial says that it is currently seeking patients. The trial was first posted on February 21st, 2019 and was last edited on September 23rd, 2020. This study aims to enroll 200 patients from 43 different locations."
Answered by AI
In how many different medical centers is this research project being conducted today?
"43 different sites are running this trial at the moment. If you want to enroll, it would be helpful to choose a location near you from the list of Jackson, Bethlehem, Fairway and other cities."
Answered by AI
What is the total pool of patients for this research project?
"That is correct. The website clinicaltrials.gov provides data that this trial, which was first announced on February 21st, 2019, is actively recruiting patients as of September 23rd, 2020. In total, the study needs 200 individuals from 43 different locations."
Answered by AI
Who else is applying?
What site did they apply to?
University of Kansas Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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