Clinical trial NCT05429970: A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Official title: Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Keywords: ovarian cancer
propranolol
etodolac
MBRT
mind-body resilience training
music therapy
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: Number of participants successfully completing over 80% of the bundled interventions
timeFrame: 21 days after surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited protocol activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kara Long Roche, MD
role: PRINCIPAL_INVESTIGATOR
References: