Oral Supplementation to Enhance Recovery Pilot Study

August 22, 2022 updated by: M.D. Anderson Cancer Center

The goal of this clinical research study is to learn the supplements Pro-Stat (which has l-arginine and also contains protein) and omega-3 fatty acids will be well tolerated in patients who have radical cystectomy for bladder cancer. Researchers also want to learn how these medications affect inflammation and recovery for these surgical patients.

This is an investigational study. Pro-Stat is not FDA-approved to treat any specific condition or disease. Omega-3 fatty acids are FDA-approved to treat high triglyceride levels. Their use to treat inflammation and help improve recovery after bladder cancer surgery is investigational.

The study doctor can explain how the supplements are designed to work.

Up to 46 participants will be enrolled in this study. All will take part at MD Anderson.

Study Overview

Detailed Description

If you agree to take part in this study, you will be asked to perform a few tasks to learn about your strength, memory, and nutrition. These should take about 20 minutes to complete.

Study Groups:

You will be randomly assigned (as in the flip of a coin) into 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

  • If you are in Group 1, you will receive the Pro-Stat and omega-3 fatty acid supplements.
  • If you are in Group 2, you will not receive the Pro-Stat and omega-3 fatty acid supplements.

You will be asked to write down any supplements you take in a diary that will be provided to you. You should write down any supplements you take for the week before and 2 weeks after surgery. Please bring this diary to your follow up appointment after surgery.

Supplement Administration:

If you are in Group 1, you will receive the omega-3 fatty acids in a pill bottle and the Pro-Stat in foil packets. You should take each supplement 4 times daily. Omega-3 fatty acid capsules should be swallowed whole and should not be opened, chewed, or crushed.

Packets of Pro-Stat may be mixed with other liquids or food. If vomiting occurs, do not replace the vomited dose. If you miss a dose, you may take an extra dose that same day.

You should bring all supplements you haven't taken with you to your 14 day visit after surgery.

Length of Study Participation:

Your doctor may lower the dose of the supplements if you experience any serious side effects that may be related to the supplements. If these side effects continue after the dose has been lowered, you will no longer be able to take the supplements. You may also be taken off study if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Surgery:

You will have your standard-of-care surgery. You will receive a separate consent for the surgery that explains the procedure and the risks.

Study/Follow-Up Visits:

Before Surgery:

  • Blood (about 8 teaspoons) will be drawn for routine tests, protein testing, biomarker testing, to check your cholesterol, liver function, your amino acid levels, and to test for inflammatory markers. Biomarkers are found in the blood and may be related to your reaction to the supplements.
  • Urine will be collected for routine tests.
  • Blood (about 4 teaspoons) will also be drawn and stored at MD Anderson for future testing as a part of this study.

Day 1 After Surgery:

  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • Blood (about 4 teaspoons) will also be drawn and stored at MD Anderson for future testing as a part of this study.

Day 2 After Surgery, blood (about 2 teaspoons) will be drawn for routine tests.

Day 3 After Surgery:

  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • Blood (about 4 teaspoons) will also be drawn and stored at MD Anderson for future testing as a part of this study.

On your Day of Discharge from the hospital:

  • Blood (about 2 teaspoons) will be drawn for routine tests.
  • Urine will be collected for routine tests.

Day 14 After Surgery:

  • Blood (about 2 teaspoons) will be drawn for routine tests, to check your cholesterol, your liver function, and your amino acid levels.
  • Urine will be collected for routine tests.
  • Blood (about 4 teaspoons) will also be drawn and stored at MD Anderson for future testing as a part of this study.

You weight will be measured at all of the above visits and information will be collected from your medical record.

Day 90 After Surgery, you will have a physical exam and your weight will be recorded.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All patients undergoing RC for bladder cancer with urinary diversion at MD Anderson Cancer Center (MDACC). All races and ethnicities will be included
  2. Patients must be willing to spend time for the study
  3. Patient must provide signed informed consent.
  4. Male or female, age >/= 18 years.
  5. Adequate hepatic function: alkaline phosphatase </= 1.5 x Upper Limit of Normal (ULN); total bilirubin, aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) </= 1.5 x ULN; international normalized ratio (INR) <1.3 (or <3 if on anticoagulant therapy).

Exclusion Criteria:

  1. Subjects will be excluded if they do not attend pre-operative clinic dedicated to RC subjects.
  2. Subjects with allergies to any supplements.
  3. Subjects with galactosemia will be excluded.
  4. Subjects may be excluded if they have known autoimmune inflammatory disease. (e.g. rheumatoid arthritis, ulcerative colitis, gout, chronic steroids).
  5. Hepatic impairment: alkaline phosphate > 1.5 x ULN; total bilirubin, AST, and ALT > 1.5 x ULN; INR >1.3 (or >3 if on anticoagulant therapy).
  6. Previously unable to tolerate either supplement due to taste or gastrointestinal (GI) side effects.
  7. Any active malignancies being treated other than bladder cancer (incidentally found prostate cancer at RC is acceptable).
  8. Unwillingness or inability to comply with mandated blood draws.
  9. Any previous immunotherapy with immune checkpoint inhibitors such was Nivolumab, Atezolizumab and others in the class

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunonutrition: ARS + Omega-3 Fatty Acids

Participants take 1 ounce (30mls) of Arginine recovery supplement (ARS) four times daily 5 days preoperatively and 14 days postoperatively.

Participants also given omega-3 fatty acids, 1 gram four times a day, 4 grams total per day. This will be started 7 days preoperatively and continued 14 days postoperatively.

Participants take 1 ounce (30mls) of Arginine recovery supplement four times daily 5 days preoperatively and 14 days postoperatively.
Other Names:
  • ARS
Participants given omega-3 fatty acids, 1 gram four times a day, 4 grams total per day. This will be started 7 days preoperatively and continued 14 days postoperatively.
No Intervention: No Immunonutrition
Participants receive regular enhanced recovery after surgery (ERAS)/Optimized Surgical Journey (OSJ) education and follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination if novel immunonutrition regimen is able to be implemented with adequate compliance in Radical Cystectomy (RC) patients: Participant Compliance
Time Frame: 21 days after starting immunonutrition regimen
Participant compliance defined as "Yes" if a participant completes at least 16 out of the total 21 days' treatment.
21 days after starting immunonutrition regimen

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Length of Hospital Stay>7 Days
Time Frame: 90 days after surgery
Poor recovery determined by length of stay greater than 7 days.
90 days after surgery
Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Postoperative Infections
Time Frame: 90 days after surgery
Poor recovery determined by any postoperative infection.
90 days after surgery
Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Hospital Readmissions
Time Frame: 90 days after surgery
Poor recovery determined by hospital readmission within 90 days after radical cystectomy.
90 days after surgery
Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Deaths within 90 days of Cystectomy
Time Frame: 90 days after surgery
Poor recovery determined by death within 90 days of cystectomy.
90 days after surgery
Decrease in Inflammatory Response of Serum Interleukin-6 Levels After Radical Cystectomy (RC) postoperative day 1
Time Frame: 1 day after surgery
IL-6 levels drawn postoperative day 1 within 24 hours of anesthesia induction. This used to create a response curve based on the administration of immunonutrition.
1 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2017

Primary Completion (Actual)

May 25, 2022

Study Completion (Actual)

May 25, 2022

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 28, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-0117
  • NCI-2018-01132 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malignant Neoplasms of Urinary Tract

Clinical Trials on Arginine recovery supplement

3
Subscribe