A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
NCT ID: NCT05429970
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
35 participants
INTERVENTIONAL
2022-06-17
2026-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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PSRB
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.
Mind-body resilience training
MBRT is a meditation technique used to achieve relaxation)
Music therapy
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
Propranolol
Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
Etodolac
Etodolac 400 mg PO BID (for 21 consecutive days)
Standard of Care
Participants will receive usual care (study interventions not specifically recommended)
No interventions assigned to this group
Interventions
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Mind-body resilience training
MBRT is a meditation technique used to achieve relaxation)
Music therapy
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
Propranolol
Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
Etodolac
Etodolac 400 mg PO BID (for 21 consecutive days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kara Long Roche, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Kara Long Roche, MD
Role: primary
Kara Long Roche, MD
Role: primary
Kara Long Roche, MD
Role: primary
Kara Long Roche, MD
Role: primary
Kara Long Roche, MD
Role: primary
Kara Long Roche, MD
Role: primary
Kara Long Roche, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-049
Identifier Type: -
Identifier Source: org_study_id
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