Recruiting NCT05429970
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mind-body resilience training, Music therapy, Propranolol, Etodolac.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Ovarian Carcinoma, Stage II Ovary Cancer, Stage II Ovarian Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
Overview
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).
Interventions
- Behavioral Mind-body resilience training
MBRT is a meditation technique used to achieve relaxation) - Behavioral Music therapy
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements - Drug Propranolol
Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16) - Drug Etodolac
Etodolac 400 mg PO BID (for 21 consecutive days)
Primary outcome measures
- Number of participants successfully completing over 80% of the bundled interventions [Time frame: 21 days after surgical procedure]
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, 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 7 centers
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale
Identifiers
NCT: NCT05429970 · 22-049