Health Trials

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

ConditionsOvarian CancerOvarian CarcinomaStage II Ovary CancerStage II Ovarian CancerStage III Ovary CancerStage III Ovarian CancerStage IV Ovary CancerStage IV Ovarian CancerEpithelial Ovarian CancerFallopian Tube CancerStage II Fallopian Tube CancerStage III Fallopian Tube CancerStage IV Fallopian Tube CancerPrimary Peritoneal Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Mind-body resilience training
  • Music therapy
  • Propranolol
  • Etodolac

Treatment groups

35 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov