Ovarian Cancer Clinical Trial
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Summary
The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).
Eligibility Criteria
Inclusion Criteria:
Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment
Scheduled to undergo exploratory laparotomy and PDS or IDS
Scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and COX2 inhibitor 7 days preoperatively
Age ≥18 years
ASA score of 1 to 3
Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent
Exclusion Criteria:
Chronic treatment with any β-blocker or COX inhibitor
Contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease)
Contraindication for COX2 inhibitor therapy (renal failure [creatinine level >1.5 mg/dL], significant liver failure [known cirrhosis, bilirubin level >2], active peptic disease), or current use of oral anticoagulant)
Contraindication for regional epidural anesthesia
Chronic autoimmune disease
Active infection
Pregnant
Minimally invasive procedure
Participation in another clinical trial that interferes with this study
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 7 Locations for this study
Basking Ridge New Jersey, 07920, United States More Info
Middletown New Jersey, 07748, United States More Info
Montvale New Jersey, 07645, United States More Info
Commack New York, 11725, United States More Info
Harrison New York, 10604, United States More Info
New York New York, 10065, United States More Info
Uniondale New York, 11553, United States More Info
How clear is this clinincal trial information?