A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Recruiting
N/AInterventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
35 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
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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).
Trial Locations
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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,…
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
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