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

Not Applicable

Recruiting

• Conditions: Stage III Ovary Cancer; Ovarian Carcinoma; Fallopian Tube Cancer; Ovarian Cancer; Stage III Ovarian Cancer; Stage IV Ovarian Cancer; Stage II Fallopian Tube Cancer; Stage III Fallopian Tube Cancer; Stage II Ovary Cancer; Stage IV Ovary Cancer
• Interventions: Behavioral: Mind-body resilience training; Behavioral: Music therapy; Drug: Propranolol; Drug: Etodolac

• Registration Number: NCT05429970
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-17
• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-06-17
• Study Completion: 2026-06-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PSRB	Mind-body resilience training	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.
PSRB	Music therapy	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.
PSRB	Propranolol	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.
PSRB	Etodolac	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.

Primary Outcome Measures

Name	Time	Method
Number of participants successfully completing over 80% of the bundled interventions	21 days after surgical procedure	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, 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

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States