What side effects are associated with this type of intervention?

Common treatments for ovarian cancer include Propranolol, Etodolac, MBRT, and Music Therapy. Propranolol, a beta-blocker, can cause central nervous system side effects such as mood changes, fatigue, and sleep disturbances. Etodolac, an NSAID, may lead to gastrointestinal issues like ulcers, bleeding, and kidney problems. MBRT (Mind-Body Resilience Training) and Music Therapy are generally safe and aim to improve mental resilience and promote relaxation, respectively, though their efficacy can vary among individuals.

What prior FDA approvals exist?

FDA-approved treatments for ovarian cancer primarily include chemotherapeutic agents, targeted therapies, and maintenance treatments. Key drugs include PARP inhibitors like olaparib, rucaparib, and niraparib, which target DNA repair mechanisms in cancer cells. Bevacizumab, an angiogenesis inhibitor, is also approved for use in combination with chemotherapy. While propranolol and etodolac are not approved specifically for ovarian cancer, they may be used off-label to manage symptoms such as stress and inflammation. Mind-body resilience training (MBRT) and music therapy are supportive care strategies aimed at improving patients' mental health and quality of life, though they are not FDA-approved treatments for cancer itself.

What other types of research exist?

Promising novel alternatives for ovarian cancer patients in 2024 include: <ol> <li>Immune Checkpoint Inhibitors: Pembrolizumab and Dostarlimab for tumors with specific genetic markers (dMMR, MSI-H).</li> <li>PARP Inhibitors: Used as maintenance therapy in platinum-sensitive recurrent ovarian cancer.</li> <li>Angiogenesis Inhibitors: Bevacizumab, which can be combined with chemotherapy and used as maintenance therapy.</li> <li>Psychosocial Support and Pain-Coping Skills Training: Programs like painTRAINER for improving mental resilience and coping with pain.</li> <li>Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs): For managing stress and improving mental health.</li> </ol>

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Stress Reduction Therapies for Ovarian Cancer

N/A

Recruiting

Led By Kara Long Roche, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent

Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment

Must not have

Chronic treatment with any β-blocker or COX inhibitor

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days after surgical procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if propranolol, etodolac, MBRT, and music therapy can reduce stress in patients having major surgeries. These treatments aim to lower anxiety, pain, and promote relaxation. Propranolol has been found to reduce anxiety in various medical settings, including day case surgery.

Who is the study for?

This trial is for adults over 18 with advanced ovarian, fallopian tube, or peritoneal carcinoma who are scheduled for surgery. Participants must understand the study and consent to it. Exclusions include active infections, pregnancy, chronic autoimmune diseases, other clinical trial participation that conflicts with this one, and certain medical conditions like asthma or liver failure.

What is being tested?

The PRESERVE study tests if propranolol and etodolac combined with mind-body resilience training and music therapy can reduce stress in patients undergoing surgery for ovarian cancer better than standard care without these interventions.

What are the potential side effects?

Possible side effects may include reactions to propofol such as drowsiness or nausea; etodolac could cause stomach issues or headaches; mind-body training is generally safe but might bring up emotional discomfort; music therapy is typically risk-free.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study's goals, can follow the rules, and agree to participate.

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I have advanced ovarian, fallopian tube, or peritoneal cancer.

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I am 18 years old or older.

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I am scheduled for surgery to examine my abdomen and remove as much cancer as possible.

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My health is good to moderately impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on long-term medication for heart issues or pain that includes β-blockers or COX inhibitors.

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I cannot take COX2 inhibitors due to kidney, liver issues, or stomach ulcers.

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I currently have an infection.

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I cannot have regional epidural anesthesia due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days after surgical procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days after surgical procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days after surgical procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PSRBExperimental Treatment4 Interventions

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.

Group II: Standard of CareActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

2010

Completed Phase 4

~1290

Etodolac

2012

Completed Phase 4

~730

Music therapy

2016

Completed Phase 4

~1220

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include Propranolol, Etodolac, MBRT, and Music Therapy. Propranolol, a beta-blocker, reduces heart rate and blood pressure, potentially lowering physiological stress during treatment. Etodolac, an NSAID, reduces inflammation and pain, helping manage symptoms. MBRT improves mental resilience, aiding patients in coping with emotional and psychological stress. Music Therapy promotes relaxation and reduces anxiety. These treatments are important as they address both physical and psychological aspects of ovarian cancer, potentially improving treatment outcomes and quality of life.

Aspirin use correlates with survival in women with clear cell ovarian cancer.