Brief Title
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Official Title
Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
Brief 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 and also if it's
better than the standard-of-care approach (no intervention for reducing stress).
Study Type
Interventional
Primary Outcome
Number of participants successfully completing over 80% of the bundled interventions
Condition
Ovarian Cancer
Intervention
Mind-body resilience training
Study Arms / Comparison Groups
PSRB
Description: Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
30
Start Date
June 17, 2022
Completion Date
June 17, 2024
Primary Completion Date
June 17, 2024
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
- 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], or active
peptic disease)
- Contraindication for regional epidural anesthesia
- Chronic autoimmune disease
- Active infection
- Pregnant
- Minimally invasive procedure
- Participation in another clinical trial that interferes with this study
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Kara Long Roche, MD, 212-639-7043, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05429970
Organization ID
22-049
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Study Sponsor
Kara Long Roche, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
June 2022