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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Stage IV Ovary Cancer; Epithelial Ovarian Cancer; Stage III Ovarian Cancer; Stage IV Fallopian Tube Cancer; Ovarian Carcinoma; Stage II Fallopian Tube Cancer; Fallopian Tube Cancer; Ovarian Cancer; Stage III Ovary Cancer; Stage III Fallopian Tube Cancer; Stage II Ovarian Cancer; Primary Peritoneal Carcinoma; Stage II Ovary Cancer; Stage IV Ovarian Cancer

Treatments: Behavioral: Music therapy; Behavioral: Mind-body resilience training; Drug: Propranolol; Drug: Etodolac

Study type: Interventional

Funder types: Other

Identifiers

NCT05429970

22-049

Details and patient eligibility

About

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).

Enrollment: 35 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

PSRB

Experimental group

Description:

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.

Treatment:

Drug: Etodolac

Drug: Propranolol

Behavioral: Mind-body resilience training

Behavioral: Music therapy

Standard of Care

No Intervention group

Description:

Participants will receive usual care (study interventions not specifically recommended)