Last updated: May 1, 2024
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting
Phase
N/A
Condition
Carcinoma
Ovarian Cancer
Pelvic Cancer
Treatment
Propofol
Propranolol
Etodolac
Clinical Study ID
NCT05429970
22-049
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritonealcarcinoma 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 totake 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
Exclusion Criteria:
- Chronic treatment with any β-blocker or COX inhibitor
- Contraindication for β-blocker therapy (asthma, second- or third-degreeatrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heartfailure, pheochromocytoma, peripheral vascular disease)
- Contraindication for COX2 inhibitor therapy (renal failure [creatinine level >1.5mg/dL], significant liver failure [known cirrhosis, bilirubin level >2], active pepticdisease), 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
Study Design
Total Participants: 35
Treatment Group(s): 5
Primary Treatment: Propofol
Phase:
Study Start date:
June 17, 2022
Estimated Completion Date:
June 17, 2025
Connect with a study center
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York 11553
United StatesActive - Recruiting
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