ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 212 for:    Oral Cancer | Recruiting Studies | NIH

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

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Malignant Neoplasms of Urinary Tract Drug: Arginine recovery supplement Dietary Supplement: Omega-3 Fatty Acids Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Oral Supplementation to Enhance Recovery Pilot Study
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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.

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.

No Intervention: No Immunonutrition
Participants receive regular enhanced recovery after surgery (ERAS)/Optimized Surgical Journey (OSJ) education and follow up.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204266


Contacts
Contact: Neema Navai, MD 713-792-3250 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Neema Navai, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03204266     History of Changes
Other Study ID Numbers: 2017-0117
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
urinary tract
Bladder cancer
Radical cystectomy
Omega-3 Fatty Acids

Additional relevant MeSH terms:
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site