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

Study Overview
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Brief Summary
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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).

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

Conditions
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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

Intervention / Treatment
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* Behavioral: Mind-body resilience training
* Behavioral: Music therapy
* Drug: Propofol
* Drug: Etodolac


Participation Criteria
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Eligibility Criteria
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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], or active peptic disease) Contraindication for regional epidural anesthesia Chronic autoimmune disease Active infection Pregnant Minimally invasive procedure Participation in another clinical trial that interferes with this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSRB<br>Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed. | Behavioral: Mind-body resilience training<br>* MBRT is a meditation technique used to achieve relaxation)<br>* Other names: MBRT;Behavioral: Music therapy<br>* Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements<br>Drug: Propofol<br>* Pre-op: 20 mg BID p.o. (preop D7 - preop D1) Day of Surgery: total intravenous anesthesia/TIVA using propofol as the main anesthetic drug Post-op: 20 mg BID p.o. (until POD 14)<br>Drug: Etodolac<br>* Pre-op: 400 mg BID p.o. (preop D7 - preop D1) Post-op: 400 mg BID p.o. (until POD 14)<br>|
| No Intervention: Standard of Care<br>Participants will receive usual care (study interventions not specifically recommended) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants successfully completing over 80% of the bundled interventions | The primary objective of this study is to investigate the feasibility of implementing a multimodal PSRB in women undergoing PDS or IDS for advanced EOC. This will be measured as number of patients successfully completing over 80% of the bundled interventions, including a preoperative integrative medicine session, postoperative integrative medicine session, total intravenous anesthesia on day of surgery, and perioperative beta blocker and COX2 inhibitor | 21 days after surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, propranolol, etodolac, MBRT, mind-body resilience training, music therapy, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma