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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05429970

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

4.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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 and also if it's better than the standard-of-care approach (no intervention for reducing stress).

Condition or Disease	Intervention/Treatment	Phase
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	Behavioral: Mind-body resilience training Behavioral: Music therapy Drug: Propofol Drug: Etodolac	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 17, 2022

Anticipated Primary Completion Date :

Jun 17, 2024

Anticipated Study Completion Date :

Jun 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PSRB Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively.	Behavioral: Mind-body resilience training MBRT is a meditation technique used to achieve relaxation) Other Names: MBRT 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: 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) Drug: Etodolac Pre-op: 400 mg BID p.o. (preop D7 - preop D1) Post-op: 400 mg BID p.o. (until POD 14)
No Intervention: Standard of Care Participants will receive usual care (study interventions not specifically recommended)

Arm

Intervention/Treatment

Experimental: PSRB

Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively.

Behavioral: Mind-body resilience training

MBRT is a meditation technique used to achieve relaxation)

Other Names:

MBRT

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: 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)

Drug: Etodolac

Pre-op: 400 mg BID p.o. (preop D7 - preop D1) Post-op: 400 mg BID p.o. (until POD 14)

No Intervention: Standard of Care

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

Outcome Measures

Primary Outcome Measures

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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)	Commack	New York	United States	11725
5	Memoral Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York	United States	11553