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NCT05429970 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05429970
Other study ID # 22-049
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 17, 2022
Est. completion date June 17, 2024

Study information
Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact Kara Long Roche, MD
Phone 212-639-7043
Email longrock@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 17, 2024
Est. primary completion date June 17, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 ß-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 ß-blocker or COX inhibitor - Contraindication for ß-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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mind-body resilience training
MBRT is a meditation technique used to achieve relaxation)
• Music therapy
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
Drug:
• Propofol
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)
• Etodolac
Pre-op: 400 mg BID p.o. (preop D7 - preop D1) Post-op: 400 mg BID p.o. (until POD 14)

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (Limited protocol activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
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

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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