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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05429970
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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).

Condition or disease Intervention/treatment Phase
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 Behavioral: Mind-body resilience training Behavioral: Music therapy Drug: Propofol Drug: Etodolac Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
Actual Study Start Date : June 17, 2022
Estimated Primary Completion Date : June 17, 2024
Estimated Study Completion Date : June 17, 2024


Arm Intervention/treatment
Experimental: PSRB
Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively.
Behavioral: Mind-body resilience training
MBRT is a meditation technique used to achieve relaxation)
Other Name: MBRT

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

Drug: Propofol
Pre-op: 20 mg BID p.o. (preop D7 - preop D1) Day of Surgery: total intravenous anesthesia/TIVA using propofol as the main anesthetic drug Post-op: 20 mg BID p.o. (until POD 14)

Drug: Etodolac
Pre-op: 400 mg BID p.o. (preop D7 - preop D1) Post-op: 400 mg BID p.o. (until POD 14)

No Intervention: Standard of Care
Participants will receive usual care (study interventions not specifically recommended)



Primary Outcome Measures :
  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 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05429970


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

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Kara Long Roche, MD    646-608-3787      
Memorial Sloan Kettering Monmouth (Limited protocol activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Kara Long Roche, MD    646-608-3787      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Kara Long Roche, MD    646-608-3787      
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) Recruiting
Commack, New York, United States, 11725
Contact: Kara Long Roche, MD    646-608-3787      
Memoral Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Kara Long Roche, MD    646-608-3787      
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Kara Long Roche, MD    646-608-3787      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Kara Long Roche, MD    646-608-3787      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Kara Long Roche, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05429970    
Other Study ID Numbers: 22-049
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
ovarian cancer
propranolol
etodolac
MBRT
mind-body resilience training
music therapy
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma
Additional relevant MeSH terms:
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Carcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Etodolac
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents