NCT05429970

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
BEHAVIORAL	Mind-body resilience training	MBRT is a meditation technique used to achieve relaxation)
BEHAVIORAL	Music therapy	Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
DRUG	Propranolol	Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
DRUG	Etodolac	Etodolac 400 mg PO BID (for 21 consecutive days)

Timeline

• Start date: 2022-06-17
• Primary completion: 2026-06-17
• Completion: 2026-06-17
• First posted: 2022-06-24
• Last updated: 2025-05-18

Locations

7 sites across 1 country: United States