Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05429970

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-05-18

35

Participants Needed

7

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed by imaging, CA125, and clinical assessment
  • Scheduled for exploratory laparotomy and primary or interval debulking surgery
  • Surgery scheduled with at least 10 days lead time to allow 7 days of preoperative beta-blocker and COX2 inhibitor treatment
  • Age 18 years or older
  • ASA physical status score between 1 and 3
  • Ability to understand study objectives, comply with protocol, and provide informed consent
Not Eligible

You will not qualify if you...

  • Chronic use of any beta-blocker or COX inhibitor
  • Contraindications to beta-blockers, including asthma, advanced heart conduction blocks, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, or peripheral vascular disease
  • Contraindications to COX2 inhibitors, including renal failure (creatinine >1.5 mg/dL), significant liver failure (cirrhosis or bilirubin >2), active peptic disease, or current oral anticoagulant use
  • Contraindication for regional epidural anesthesia
  • Chronic autoimmune disease
  • Active infection
  • Pregnancy
  • Minimally invasive surgical procedures
  • Participation in another clinical trial interfering with this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

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

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

K

Kara Long Roche, MD

CONTACT

A

Anoushka Afonso, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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