A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
ID: NCT05429970
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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 or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).
MBRT is a meditation technique used to achieve relaxation)
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
Etodolac 400 mg PO BID (for 21 consecutive days)
Treatment Arms Description
Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.
Participants will receive usual care (study interventions not specifically recommended)
- 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
- 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
Primary Outcome Measures
- Number of participants successfully completing over 80% of the bundled interventions — Time Frame: 21 days after surgical procedure
The primary objective of this study is to investigate the feasibility of implementing a multimodal PSRB in women undergoing PDS or IDS for advanced EOC. This will be measured as number of patients successfully completing over 80% of the bundled interventions, including a preoperative integrative medicine session, postoperative integrative medicine session, total intravenous anesthesia on day of surgery, and perioperative beta blocker and COX2 inhibitor
This trial is recruiting at 7 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 7 Facilities & Contact Sites
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View Official Medical/Scientific Title
Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study