RecruitingInterventional

Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study

NCT ID: NCT05429970Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-05-18

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 or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).

Arms & interventions

BehavioralMind-body resilience training
MBRT is a meditation technique used to achieve relaxation)
BehavioralMusic therapy
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
DrugPropranolol
Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
DrugEtodolac
Etodolac 400 mg PO BID (for 21 consecutive days)

Outcome measures

Primary

Number of participants successfully completing over 80% of the bundled interventions
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
Time frame: 21 days after surgical procedure

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

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