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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Mind-body resilience training

    Behavioral

    MBRT is a meditation technique used to achieve relaxation)

  • Music therapy

    Behavioral

    Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements

  • Propranolol

    Drug

    Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)

  • Etodolac

    Drug

    Etodolac 400 mg PO BID (for 21 consecutive days)

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: PSRBExperimental treatment 4 interventions
Group B: Standard of CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Number of participants successfully completing over 80% of the bundled interventions

The primary objective of this study is to investigate the feasibility of implementing a multimodal PSRB in women undergoing PDS or IDS for advanced EOC. This will be measured as number of patients successfully completing over 80% of the bundled interventions, including a preoperative integrative medicine session, postoperative integrative medicine session, total intravenous anesthesia on day of surgery, and perioperative beta blocker and COX2 inhibitor

Time frame
21 days after surgical procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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