A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

• Status: Recruiting
• Trial end date: 2024-06-17
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Etodolac; Propofol

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

• 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], or active peptic disease)

• Contraindication for regional epidural anesthesia

• Chronic autoimmune disease

• Active infection

• Pregnant

• Minimally invasive procedure

• Participation in another clinical trial that interferes with this study