What this study is
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).
What's being tested
- Mind-body resilience training
Intervention · BEHAVIORAL
MBRT is a meditation technique used to achieve relaxation)
- Music therapy
Intervention · BEHAVIORAL
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
- Propranolol
Intervention · DRUG
Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
- Etodolac
Intervention · DRUG
Etodolac 400 mg PO BID (for 21 consecutive days)
Study details
- Official title
- Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Conditions
- 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
- Enrolling
- 35 people
- Starts
- 2022-06-17
- Est. completion
- 2027-06-17
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (7)
7 openContact for every open site
- Kara Long Roche, MD · Contact646-608-3787
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
RecruitingMemorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
RecruitingMemorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
RecruitingMemorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, United States
RecruitingMemorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
RecruitingMemorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
RecruitingMemorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Recruiting
Study team
Sponsor
Memorial Sloan Kettering Cancer Center
Study ID 22-049
Principal investigator
Kara Long Roche, MD
Memorial Sloan Kettering Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.