NCT03204266

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Aug 2017

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 16, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

4.8 years

First QC Date

June 28, 2017

Last Update Submit

August 22, 2022

Conditions

Malignant Neoplasms of Urinary Tract

Keywords

urinary tractBladder cancerRadical cystectomyOmega-3 Fatty Acids

Outcome Measures

Primary Outcomes (1)

  • Determination if novel immunonutrition regimen is able to be implemented with adequate compliance in Radical Cystectomy (RC) patients: Participant Compliance

    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 Outcomes (5)

  • Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Length of Hospital Stay>7 Days

    90 days after surgery

  • Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Postoperative Infections

    90 days after surgery

  • Determination if Poor Recovery is Associated With the Use Immunonutrition Before and After Radical Cystectomy (RC): Hospital Readmissions

    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

    90 days after surgery

  • Decrease in Inflammatory Response of Serum Interleukin-6 Levels After Radical Cystectomy (RC) postoperative day 1

    1 day after surgery

Study Arms (2)

Immunonutrition: ARS + Omega-3 Fatty Acids

EXPERIMENTAL

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 supplementDietary Supplement: Omega-3 Fatty Acids

No Immunonutrition

NO INTERVENTION

Participants receive regular enhanced recovery after surgery (ERAS)/Optimized Surgical Journey (OSJ) education and follow up.

Interventions

Arginine recovery supplementDRUG

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

Also known as: ARS
Immunonutrition: ARS + Omega-3 Fatty Acids
Omega-3 Fatty AcidsDIETARY_SUPPLEMENT

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.

Immunonutrition: ARS + Omega-3 Fatty Acids

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients undergoing RC for bladder cancer with urinary diversion at MD Anderson Cancer Center (MDACC). All races and ethnicities will be included
  • Patients must be willing to spend time for the study
  • Patient must provide signed informed consent.
  • Male or female, age \>/= 18 years.
  • 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).

You may not qualify if:

  • Subjects will be excluded if they do not attend pre-operative clinic dedicated to RC subjects.
  • Subjects with allergies to any supplements.
  • Subjects with galactosemia will be excluded.
  • Subjects may be excluded if they have known autoimmune inflammatory disease. (e.g. rheumatoid arthritis, ulcerative colitis, gout, chronic steroids).
  • 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).
  • Previously unable to tolerate either supplement due to taste or gastrointestinal (GI) side effects.
  • Any active malignancies being treated other than bladder cancer (incidentally found prostate cancer at RC is acceptable).
  • Unwillingness or inability to comply with mandated blood draws.
  • Any previous immunotherapy with immune checkpoint inhibitors such was Nivolumab, Atezolizumab and others in the class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Urologic NeoplasmsUrinary Bladder Neoplasms

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrologic DiseasesUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Neema Navai, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

June 29, 2017

Study Start

August 16, 2017

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations

US(1)