Ovarian CancerNCT05429970
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)
A study testing Mind-body resilience training, Music therapy and Propranolol in people with Ovarian Cancer and Ovarian Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Carcinoma, Stage II Ovary Cancer
- What is being tested?
- Mind-body resilience training, Music therapy and Propranolol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Jun 2022to 17 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnant
- Minimally invasive procedure
- Participation in another clinical trial that interferes with this study
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Kara Long Roche, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725
Kara Long Roche, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Kara Long Roche, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Kara Long Roche, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Kara Long Roche, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Kara Long Roche, MD, 646-608-3787
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Kara Long Roche, MD, 646-608-3787
About this study
Official title: Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
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).
- Conditions
- Ovarian Cancer, Ovarian Carcinoma, Stage II Ovary Cancer, Stage II Ovarian Cancer, Stage III Ovary Cancer, Stage III Ovarian Cancer
- Being tested
- Mind-body resilience training, Music therapy, Propranolol, Etodolac
- Keywords
- ovarian cancer, propranolol, etodolac, MBRT, mind-body resilience training, music therapy, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body resilience trainingBehavioural
Also called MBRT
MBRT is a meditation technique used to achieve relaxation)
Music therapyBehavioural
Music listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements
PropranololDrug
Propranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16)
EtodolacDrug
Etodolac 400 mg PO BID (for 21 consecutive days)
| Study group | Role | What they receive |
|---|---|---|
| PSRB | Experimental | 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. Receives: Behavioral: Mind-body resilience training; Behavioral: Music therapy; Drug: Propranolol; Drug: Etodolac |
| Standard of Care | No intervention | Participants will receive usual care (study interventions not specifically recommended) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start17 Jun 2022
- Primary completion17 Jun 2027 (estimated)
- Study completion17 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kara Long Roche, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429970
- Sponsor's protocol ID
- 22-049
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2022
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT05429970
- Acronym / sponsor ID
- 22-049
- Conditions
- Ovarian Cancer, Ovarian Carcinoma, Stage II Ovary Cancer, Stage II Ovarian Cancer, Stage III Ovary Cancer, Stage III Ovarian Cancer
- Keywords
- ovarian cancer, propranolol, etodolac, MBRT, mind-body resilience training, music therapy, Epithelial Ovarian Cancer, Fallopian Tube Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 17 Jun 2027 (estimated)
- Study completion
- 17 Jun 2027 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSRB | Experimental | Behavioral: Mind-body resilience training, Behavioral: Music therapy, Drug: Propranolol, Drug: EtodolacParticipants 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. |
| Standard of Care | No intervention | –Participants will receive usual care (study interventions not specifically recommended) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-body resilience trainingAlso: MBRTMBRT is a meditation technique used to achieve relaxation) | Behavioural | PSRB |
| Music therapyMusic listening was found, in multiple trials, to significantly reduce self-reported anxiety, physiologic indicators of anxiety, and/or sedation requirements | Behavioural | PSRB |
| PropranololPropranolol 20 mg PO BID (for 21 consecutive days), Propranolol 10mg PO BID (for 3 consecutive days POD 14-16) | Drug | PSRB |
| EtodolacEtodolac 400 mg PO BID (for 21 consecutive days) | Drug | PSRB |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kara Long Roche, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body resilience training, Music therapy and Propranolol in people with Ovarian Cancer and Ovarian Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kara Long Roche, MD (212-639-7043, longrock@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants successfully completing over 80% of the bundled interventions (time frame: 21 days after surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.