NCT05429970NARecruiting
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Memorial Sloan Kettering Cancer Center
Start Date
6/17/2022
Completion Date
6/17/2027
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).
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
BEHAVIORAL
Mind-body resilience training
BEHAVIORAL
Music therapy
DRUG
Propranolol
DRUG
Etodolac
Conditions
Ovarian CancerOvarian CarcinomaStage II Ovary CancerStage II Ovarian CancerStage III Ovary CancerStage III Ovarian CancerStage IV Ovary CancerStage IV Ovarian CancerEpithelial Ovarian CancerFallopian Tube CancerStage II Fallopian Tube CancerStage III Fallopian Tube CancerStage IV Fallopian Tube CancerPrimary Peritoneal Carcinoma
Locations
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United States