RecruitingNot ApplicableNCT05429970

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

Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

35 participants

Start Date

Jun 17, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (PRESERVE) is testing whether giving stress-reducing medications — a beta-blocker to reduce the body's adrenaline response and a COX-2 inhibitor to reduce inflammation — before and during ovarian cancer surgery can improve long-term cancer outcomes by reducing the stress hormones triggered by surgery that may help cancer spread. **You may be eligible if:** - You have Stage II–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer - You are scheduled for open surgery (laparotomy) with at least 10 days lead time before the procedure - You are at least 18 years old - Your overall health is acceptable for surgery (ASA score 1–3) **You may NOT be eligible if:** - You are already taking beta-blockers or COX inhibitors regularly - You have asthma, heart block, slow heart rate, right-sided heart failure, or peripheral vascular disease (contraindications to beta-blockers) - You have kidney failure, significant liver disease, or active stomach ulcers (contraindications to COX-2 inhibitors) - You have a chronic autoimmune disease or active infection - You are pregnant - Your surgery is minimally invasive (laparoscopic) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMind-body resilience training

MBRT is a meditation technique used to achieve relaxation)

BEHAVIORALMusic therapy

Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements

DRUGPropranolol

Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)

DRUGEtodolac

Etodolac 400 mg PO BID (for 21 consecutive days)


Locations(7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

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

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

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NCT05429970


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