NCT05429970 A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
| NCT ID | NCT05429970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2022-06-17 |
| Primary Completion | 2026-06-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2022-06-17 with a primary completion date of 2026-06-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).
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
Contact & Investigator
Kara Long Roche, MD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05429970 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05429970 currently recruiting?
Yes, NCT05429970 is actively recruiting participants. Contact the research team at longrock@mskcc.org for enrollment information.
Where is the NCT05429970 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT05429970 clinical trial?
NCT05429970 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Kara Long Roche, MD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 35 participants.
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