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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jun 17, 2022

Keywords

ClinConnect Summary

The PRESERVE clinical trial is exploring whether a combination of medications, specifically propranolol and etodolac, along with mind-body resilience training and music therapy, can help reduce stress in women with advanced ovarian, fallopian tube, or primary peritoneal cancer before, during, and after their surgery. This study is comparing these stress-reducing methods to the usual care, which does not include any specific interventions for managing stress.

To participate in this trial, women aged 18 and older who have been diagnosed with advanced stages of these cancers and are scheduled for a specific type of surgery called exploratory laparotomy or primary debulking surgery may be eligible. Participants will begin taking the medications at least a week before their surgery and will receive personalized support through the mind-body training and music therapy. This study is currently looking for participants, and those interested should be able to understand the study details and provide consent to join.

Gender

FEMALE

Eligibility 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