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NCT Number: NCT05429970

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

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).

Recruiting

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Epithelial Ovarian Cancer Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Carcinoma Stage II Fallopian Tube Cancer Stage II Ovarian Cancer Stage II Ovary Cancer Stage III Fallopian Tube Cancer Stage III Ovarian Cancer Stage III Ovary Cancer Stage IV Fallopian Tube Cancer Stage IV Ovarian Cancer Stage IV Ovary Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mind-body resilience training

Behavioral

MBRT is a meditation technique used to achieve relaxation)

Other names: MBRT

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)

Primary outcomes

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

    Time frame: 21 days after surgical procedure

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anoushka Afonso, MD

CONTACT

[email protected]

212-639-8113

Kara Long Roche, MD

CONTACT

[email protected]

212-639-7043

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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