Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study

  • STATUS
    Recruiting
  • End date
    Jun 17, 2024
  • participants needed
    30
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 16 October 2022
laparotomy
carcinoma
ovarian cancer
fallopian tube
cancer antigen 125
primary peritoneal carcinoma
peritoneal carcinoma
tumor debulking
cancer of the ovary
primary debulking surgery

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 and also if it's better than the standard-of-care approach (no intervention for reducing stress).

Details
Condition Ovarian Cancer, Ovarian Carcinoma, Stage II Ovary Cancer, Stage II Ovarian Cancer, Stage III Ovary Cancer, Stage III Ovarian Cancer, Stage IV Ovary Cancer, Stage IV Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Stage II Fallopian Tube Cancer, Stage III Fallopian Tube Cancer, Stage IV Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Treatment Propofol, Music Therapy, Etodolac, Mind-body resilience training
Clinical Study IdentifierNCT05429970
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

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
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], or active peptic disease)
Contraindication for regional epidural anesthesia
Chronic autoimmune disease
Active infection
Pregnant
Minimally invasive procedure
Participation in another clinical trial that interferes with this study
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