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A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

RecruitingNAAges 18 Years - anyFemaleMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 ฮฒ-blocker and COX2 inhibitor 7 days preoperatively * Age โ‰ฅ18 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 ฮฒ-blocker or COX inhibitor * Contraindication for ฮฒ-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
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What it tests

  • Mind-body resilience training
  • Music therapy
  • Propranolol
  • Etodolac
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Where

7 sites
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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