A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Recruiting now · Not applicable
Conditions studied: Ovarian Cancer, Ovarian Carcinoma, Stage II Ovary Cancer, Stage II Ovarian Cancer, Stage III Ovary Cancer, Stage III Ovarian Cancer, Stage IV Ovary Cancer, Stage IV Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Stage II Fallopian Tube Cancer, Stage III Fallopian Tube Cancer, Stage IV Fallopian Tube Cancer, Primary Peritoneal Carcinoma
In brief
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).
Key facts
- Study ID
- NCT05429970
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 35
- Starts
- 2022-06-17
- Expected to finish
- 2027-06-17
- Last updated by the study team
- 2026-07-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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