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

Primary Purpose

Ovarian Cancer, Ovarian Carcinoma, Stage II Ovary Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mind-body resilience training
Music therapy
Propofol
Etodolac
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Cancer focused on measuring ovarian cancer, propranolol, etodolac, MBRT, mind-body resilience training, music therapy, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited protocol activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PSRB

Standard of Care

Arm Description

Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.

Participants will receive usual care (study interventions not specifically recommended)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 17, 2022
Last Updated
March 16, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05429970
Brief Title
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
Official Title
Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
June 17, 2024 (Anticipated)
Study Completion Date
June 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
ovarian cancer, propranolol, etodolac, MBRT, mind-body resilience training, music therapy, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PSRB
Arm Type
Experimental
Arm Description
Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Participants will receive usual care (study interventions not specifically recommended)
Intervention Type
Behavioral
Intervention Name(s)
Mind-body resilience training
Other Intervention Name(s)
MBRT
Intervention Description
MBRT is a meditation technique used to achieve relaxation)
Intervention Type
Behavioral
Intervention Name(s)
Music therapy
Intervention Description
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Etodolac
Intervention Description
Pre-op: 400 mg BID p.o. (preop D7 - preop D1) Post-op: 400 mg BID p.o. (until POD 14)
Primary Outcome Measure Information:
Title
Number of participants successfully completing over 80% of the bundled interventions
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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], 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kara Long Roche, MD
Phone
212-639-7043
Email
longrock@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Anoushka Afonso, MD
Phone
212-639-8113
Email
afonsoa@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Phone
646-608-3787
Facility Name
Memorial Sloan Kettering Monmouth (Limited protocol activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Phone
646-608-3787
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Phone
646-608-3787
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Phone
646-608-3787
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Phone
646-608-3787
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Phone
646-608-3787
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Long Roche, MD
Phone
646-608-3787

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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

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