Recruiting

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05429970

Conditions

Ovarian Cancer

Ovarian Carcinoma

Stage II Ovary Cancer

Stage II Ovarian Cancer

Stage III Ovary Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mind-body resilience training

Music therapy

Propranolol

Etodolac

Study Details

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).

Conditions

Ovarian Cancer

Ovarian Carcinoma

Stage II Ovary Cancer

Stage II Ovarian Cancer

Stage III Ovary Cancer

Study ID

NCT05429970

Start date

Jun 17, 2022

Status verified date

Jun, 2026

Completion date

Jun 17, 2027

Anticipated

Primary completion date

Jun 17, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: PSRB

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.

no intervention: Standard of Care

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

Interventions

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

Propranolol

Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)

Etodolac

Etodolac 400 mg PO BID (for 21 consecutive days)

Primary outcome measure

Number of participants successfully completing over 80% of the bundled interventions [ Time Frame: 21 days after surgical procedure ]

Central Contacts and Locations

Central contacts

Kara Long Roche, MD

212-639-7043 longrock@mskcc.org

Anoushka Afonso, MD

212-639-8113 afonsoa@mskcc.org

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Kara Long Roche, MD

646-608-3787

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Kara Long Roche, MD

646-608-3787

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Kara Long Roche, MD

646-608-3787

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Kara Long Roche, MD

646-608-3787

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Kara Long Roche, MD

646-608-3787

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Kara Long Roche, MD

646-608-3787

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Kara Long Roche, MD

646-608-3787

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Keywords

ovarian cancer
propranolol
etodolac
MBRT
mind-body resilience training
music therapy
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-01.