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

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

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

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 States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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