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

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

Recruiting
18 years and older
Female
Phase N/A

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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).

Eligibility

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

Study details
    Ovarian Cancer
    Ovarian Carcinoma
    Stage II Ovary Cancer
    Stage II Ovarian Cancer
    Stage III Ovary Cancer
    Stage III Ovarian Cancer
    Stage IV Ovary Cancer
    Stage IV Ovarian Cancer
    Epithelial Ovarian Cancer
    Fallopian Tube Cancer
    Stage II Fallopian Tube Cancer
    Stage III Fallopian Tube Cancer
    Stage IV Fallopian Tube Cancer
    Primary Peritoneal Carcinoma

NCT05429970

Memorial Sloan Kettering Cancer Center

18 May 2024

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