RECRUITING

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

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Conditions

Ovarian 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 CarcinomapropranololetodolacMBRTmind-body resilience trainingmusic therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-06-17
Study Completion:2025-06-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05429970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment
  2. * Scheduled to undergo exploratory laparotomy and PDS or IDS
  3. * 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
  4. * Age ≥18 years
  5. * ASA score of 1 to 3
  6. * Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent
  1. * Chronic treatment with any β-blocker or COX inhibitor
  2. * 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)
  3. * 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)
  4. * Contraindication for regional epidural anesthesia
  5. * Chronic autoimmune disease
  6. * Active infection
  7. * Pregnant
  8. * Minimally invasive procedure
  9. * Participation in another clinical trial that interferes with this study

Contacts and Locations

Study Contact

Kara Long Roche, MD
CONTACT
212-639-7043
longrock@mskcc.org
Anoushka Afonso, MD
CONTACT
212-639-8113
afonsoa@mskcc.org

Principal Investigator

Kara Long Roche, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Kara Long Roche, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-17
Study Completion Date2025-06-17

Study Record Updates

Study Start Date2022-06-17
Study Completion Date2025-06-17

Terms related to this study

Keywords Provided by Researchers

  • ovarian cancer
  • propranolol
  • etodolac
  • MBRT
  • mind-body resilience training
  • music therapy
  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Carcinoma

Additional Relevant MeSH Terms

  • 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