ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Supplementation to Enhance Recovery Pilot Study

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: NCT03204266
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : January 17, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

June 28, 2017
June 29, 2017
January 17, 2018
August 16, 2017
August 2019   (Final data collection date for primary outcome measure)
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.
Decrease in Inflammatory Response of Serum Interleukin-6 Levels After Radical Cystectomy (RC) [ 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.
Complete list of historical versions of study NCT03204266 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC) [ Time Frame: 90 days after surgery ]
    Poor recovery determined by length of stay greater than 7 days.
  • Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC) [ Time Frame: 90 days after surgery ]
    Poor recovery determined by any postoperative infection.
  • Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC) [ Time Frame: 90 days after surgery ]
    Poor recovery determined by hospital readmission within 90 days after radical cystectomy.
  • Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC) [ Time Frame: 90 days after surgery ]
    Poor recovery determined by death within 90 days of cystectomy.
Not Provided
Not Provided
 
Oral Supplementation to Enhance Recovery Pilot Study
Oral Supplementation to Enhance Recovery Pilot Study

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.

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.

Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Malignant Neoplasms of Urinary Tract
  • Drug: Arginine recovery supplement
    Participants take 1 ounce (30mls) of Arginine recovery supplement four times daily 5 days preoperatively and 14 days postoperatively.
    Other Name: ARS
  • Dietary Supplement: Omega-3 Fatty Acids
    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.
  • 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.

    Interventions:
    • Drug: Arginine recovery supplement
    • Dietary Supplement: Omega-3 Fatty Acids
  • No Intervention: No Immunonutrition
    Participants receive regular enhanced recovery after surgery (ERAS)/Optimized Surgical Journey (OSJ) education and follow up.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
Same as current
August 2019
August 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Neema Navai, MD 713-792-3250 CR_Study_Registration@mdanderson.org
United States
 
 
NCT03204266
2017-0117
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Neema Navai, MD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP