Actively Recruiting
Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial) A Prospective Randomized Pilot Study
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-18
35
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of propranolol and etodolac combined with mind-body resilience training (MBRT) and music therapy on reducing physiological stress in women undergoing primary debulking surgery (PDS) or interval debulking surgery (IDS) for advanced ovarian, fallopian tube, or primary peritoneal carcinoma. The study compares these interventions to the standard care approach, which does not include specific stress-reduction treatments. This pilot randomized trial aims to understand if these combined interventions better manage stress during the perioperative period. Participants will be randomly assigned to one of two groups. The experimental group will receive MBRT, music therapy, propranolol (20 mg orally twice daily for 21 days, then 10 mg twice daily on postoperative days 14-16), and etodolac (400 mg orally twice daily for 21 days) before and after surgery. Postoperative psychological interventions may also be provided from postoperative days 1 to 7 if needed. The control group will receive usual care without these specific interventions. During the study, participants will be monitored for adherence to the interventions, with success defined as completing over 80% of the bundled treatments within 21 days after surgery. Researchers will evaluate stress reduction through psychological and physiological assessments during and after the surgical procedure. The study will continue until June 2026, with participant involvement including preoperative preparation, surgery, postoperative care, and follow-up assessments.
CONDITIONS
Brief Title
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed by imaging, CA125, and clinical assessment
- Scheduled to undergo exploratory laparotomy and primary or interval debulking surgery
- Surgery scheduled with at least 10 days lead time to allow preoperative medication
- Age 18 years or older
- ASA score between 1 and 3
- Ability to understand study objectives, comply with protocol, and provide informed consent
You will not qualify if you...
- Chronic treatment with any beta-blocker or COX inhibitor
- Contraindications to beta-blocker therapy (such as asthma, heart block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease)
- Contraindications to COX2 inhibitor therapy (including renal failure, significant liver failure, active peptic disease, current use of oral anticoagulants)
- Contraindication for regional epidural anesthesia
- Chronic autoimmune disease
- Active infection
- Pregnancy
- Minimally invasive surgical procedures
- Participation in another clinical trial that interferes with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 10 days before surgery
Participants receive mind-body resilience training, music therapy, propranolol, and etodolac before surgery to reduce perioperative stress.
Multiple visits during the preoperative period
Duration - Hospital stay duration
Participants undergo exploratory laparotomy and primary or interval debulking surgery with usual care or additional postoperative psychological interventions if needed.
Hospital visits during surgery and immediate postoperative period
Duration - 21 days post-surgery
Participants continue mind-body resilience training, music therapy, propranolol, and etodolac postoperatively for 21 days, with possible psychological interventions between postoperative days 1-7.
Daily or frequent visits or contacts during the 21-day postoperative period
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
K
Kara Long Roche, MD
A
Anoushka Afonso, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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