Stress Reduction Therapies for Ovarian Cancer

Recruiting at 8 trial locations

Overseen By Anoushka Afonso, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: β-blockers, COX2 inhibitors

Must not be taking: β-blockers, COX inhibitors

Disqualifiers: Autoimmune disease, Active infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of stress-reduction therapies, including medications like propranolol (a beta-blocker) and etodolac (a nonsteroidal anti-inflammatory drug), along with mind-body resilience training and music therapy, can help women with advanced ovarian cancer feel less stressed around the time of their surgery. It compares these therapies to the usual care, which lacks specific stress-reduction interventions. Women diagnosed with stage II-IV ovarian, fallopian tube, or primary peritoneal cancer and scheduled for major surgery might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative stress-reduction strategies that could enhance the surgical experience.

Will I have to stop taking my current medications?

The trial requires that you do not take any β-blockers or COX inhibitors, as chronic treatment with these medications is an exclusion criterion. If you are currently on these medications, you would need to stop taking them to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial—mind-body resilience training, music therapy, propranolol, and etodolac—are generally well-tolerated.

Mind-body resilience training has been tested in various studies. One study found it helpful and feasible for cancer survivors to manage fear and stress. Another study showed that focusing on sleep through mind-body techniques improved sleep and overall well-being.

Music therapy is considered safe for cancer patients. Research suggests it can enhance mental health and quality of life, especially during chemotherapy.

Propranolol, often used for heart problems, might also aid in cancer treatment by blocking stress-related pathways, according to studies. It is widely used and generally considered safe, though safety checks continue.

Etodolac, a drug used to relieve pain and reduce inflammation, can increase the risk of heart and blood vessel problems, so monitoring for these effects is important.

Overall, these treatments have been studied for other uses and are mostly well-tolerated. Those considering joining a trial should consult a healthcare provider to understand potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for ovarian cancer because they combine pharmacological and non-pharmacological approaches to tackle both physical and psychological stress. Unlike the standard of care, which typically revolves around surgery and chemotherapy, this trial includes etodolac and propranolol, two drugs that may help reduce inflammation and stress responses. Additionally, mind-body resilience training and music therapy are employed to boost emotional well-being and resilience, which could improve recovery and quality of life. This holistic approach aims to address the disease from multiple angles, offering a potentially more comprehensive treatment option.

What evidence suggests that this trial's treatments could be effective for reducing stress in ovarian cancer patients?

Research has shown that mind-body resilience training, which participants in this trial may receive, can help ovarian cancer patients by reducing stress and improving their quality of life. Another treatment option in this trial is music therapy, which studies have found decreases anxiety and emotional distress in cancer patients. Participants may also receive propranolol, a medication that evidence suggests might improve cancer outcomes by lowering the risk of recurrence, especially when used around the time of surgery. Etodolac, another drug under study in this trial, is commonly used for pain and inflammation and has shown some potential in slowing cancer cell growth. Together, these therapies aim to manage stress and possibly improve recovery and well-being for ovarian cancer patients. ^{2 4 6 7 8}

Who Is on the Research Team?

Kara Long Roche, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

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

I am undergoing a minimally invasive procedure.

I cannot take β-blockers due to certain health conditions like asthma or heart issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Intervention

Participants receive mind-body resilience training/MBRT, music therapy, propranolol, and etodolac before surgery

1 week

1 visit (in-person)

Surgical Procedure

Participants undergo primary debulking surgery (PDS) or interval debulking surgery (IDS)

1 day

1 visit (in-person)

Postoperative Intervention

Participants receive postoperative mind-body resilience training/MBRT, music therapy, propranolol, and etodolac

7 days

Daily visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 days

What Are the Treatments Tested in This Trial?

Interventions

• Etodolac
• Mind-body Resilience Training
• Music Therapy
• Propranolol

Trial Overview 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.

How Is the Trial Designed?

Group I: PSRB Experimental Treatment 4 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 Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study involving 69 patients undergoing high-dose therapy with autologous stem cell transplantation (HDT/ASCT), music therapy significantly reduced mood disturbances, showing a 37% lower total mood disturbance score compared to standard care.

Music therapy is a noninvasive and cost-effective intervention that may help alleviate psychological distress in patients with hematologic malignancies during their inpatient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. Cassileth, BR., Vickers, AJ., Magill, LA.[2015]

Integrative Music Therapy (IMT) has been shown to effectively address a wide range of needs, including behavioral, emotional, physiological, psychological, and psychosocial issues, enhancing the overall healthcare environment.

IMT is delivered by trained professionals and is designed to complement, rather than replace, traditional medical treatments, highlighting its role as a supportive therapy in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative Music Therapy: A Healing Intervention. Barnes, TB.[2019]

Music therapy is an effective complementary treatment for cancer patients, helping to improve mood, reduce stress, pain, and anxiety, and enhance relaxation during their treatment process.

Integrating music therapy into supportive cancer care can significantly promote overall wellness and improve both physical and emotional well-being, contributing to a better quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. Stanczyk, MM.[2022]

Music therapy, including the Bonny Method of Guided Imagery and Music (GIM), has been used across cultures for healing various ailments such as pain, cancer, depression, and PTSD, highlighting its broad therapeutic potential.

The article reviews the research supporting GIM therapy and includes a personal account of the treatment experience, emphasizing its effectiveness and the emotional impact of music in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided imagery and music: using the Bonny method to evoke emotion and access the unconscious. Beebe, LH., Wyatt, TH.[2022]

A systematic review of 13 trials involving 606 breast cancer patients found that arts therapies, including music and art therapy, significantly reduce anxiety levels, with a standardized mean difference of -1.10.

However, the review did not find significant effects of arts therapies on depression, quality of life, pain, or other emotional states, indicating that while beneficial for anxiety, their overall impact on other aspects of well-being remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. Boehm, K., Cramer, H., Staroszynski, T., et al.[2023]

Current research on music therapy for dementia lacks rigorous methodological design, making it difficult to draw definitive conclusions about its effectiveness.

Despite the absence of strong empirical evidence, the available studies suggest that music therapy may have potential benefits in managing dementia symptoms, highlighting the need for more well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for dementia symptoms. Koger, SM., Brotons, M.[2020]

Music therapy can significantly help pediatric oncology patients by addressing physical, social, and psychological needs, such as reducing pain and anxiety, and decreasing reliance on pain medication.

It promotes social interaction and emotional expression, enhancing relationships with healthcare providers and family, which is crucial for patients undergoing long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy research and applications in pediatric oncology treatment. Standley, JM., Hanser, SB.[2017]

The 'Music-Therapy in Internal Medicine' project at the Oberwallis district hospital has shown that music therapy can effectively support treatment by addressing emotional and psychological factors in patients with various internal medical conditions.

Music therapy is particularly beneficial for patients whose illnesses involve significant emotional components, but it is not recommended for those who are unmotivated or have short hospital stays of less than two weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy and internal medicine]. Escher, J., Höhmann, U., Wasem, C.[2006]

In a study of 113 women undergoing high complexity infertility treatments, interactive music therapy significantly reduced stress levels, with the Intervention Group showing a mean stress score of 16.12 compared to 23.13 in the Control Group (p=0.004).

The therapy led to a 39% reduction in stress symptoms in the Intervention Group, while only 14% of the Control Group experienced similar reductions, highlighting the efficacy of music therapy in managing stress during assisted reproduction techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Music Therapy on Stress Level Reduction in Women Submitted to IVF/ICSI. Prospective Randomized Study. Fleury, EAB., Approbato, MS., Barbosa, MA.[2022]

Music therapy, led by credentialed therapists, is an effective complementary treatment in oncology that helps reduce stress, anxiety, pain, and nausea in patients.

The therapy is tailored to individual patient needs and can involve active or passive participation, ensuring safety and promoting positive clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy: a valuable adjunct in the oncology setting. Mahon, EM., Mahon, SM.[2011]

Regulative Music Therapy (RMT) is effective in addressing mental and physical stress, helping to alleviate issues such as sleep disorders, cardiovascular problems, and anxiety, by promoting self-awareness and emotional balance.

RMT is not only beneficial for treating neuroses but also serves as a preventive tool to manage tension and emotional disconnection in daily life, making it versatile for various applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Regulative music therapy and training as a means for enhancing adaptive potentials and for overcoming fatigue and stress]. Tsenova, B.[2008]

Citations

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Cardiovascular/anti‐inflammatory drugs repurposed for ... We sought to investigate the anti-cancer effects of drugs repurposed from cardiology or anti-inflammatories to treat cancer.

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Etodolac: Uses, Interactions, Mechanism of Action Current data is insufficient to assess the cardiovascular risk of etodolac. ... Epithelial Ovarian Cancer / Fallopian Tube Cancer / Ovarian Cancer / Ovarian ...

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Inhibiting Beta-adrenergic and COX-2 Signaling During the ... The trial aims to assess the feasibility, safety, and biological effects of a combination of propranolol and etodolac in reducing cancer metastasis and ...

8. mskcc.org mskcc.org/cancer-care/patient-education/medications/adult/etodolac

Etodolac This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you ...