Comparing stress reduction methods to standard care for ovarian cancer patients
Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
This study is testing if a mix of medications and therapies can help reduce stress in women with advanced ovarian cancer before their surgery, compared to those getting standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05429970 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a combination of propranolol, etodolac, mind-body resilience training, and music therapy in reducing physiological stress in patients undergoing primary debulking surgery for advanced ovarian cancer. Participants will be compared to a control group receiving standard care without these interventions. The study focuses on patients diagnosed with advanced-stage epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. The interventions are designed to be administered in the lead-up to surgery, allowing for assessment of their impact on stress levels during the perioperative period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced-stage ovarian cancer scheduled for surgery.
Not a fit: Patients with chronic treatment involving β-blockers or COX inhibitors, or those with contraindications for these therapies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce stress and improve surgical outcomes for ovarian cancer patients.
How similar studies have performed: Other studies have shown promise in using mind-body interventions for stress reduction in cancer patients, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kara Long Roche, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Kara Long Roche, MD
- Email: longrock@mskcc.org
- Phone: 212-639-7043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.