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 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.

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 music therapy safe for humans?

Music therapy is generally considered safe and can be beneficial for various physical, emotional, and psychological needs. It is used as an adjunct therapy in many medical settings and has been shown to help with stress, anxiety, and other symptoms without replacing traditional medical treatments. ^{1 2 3 4 5}

How does music therapy differ from other treatments for ovarian cancer?

Music therapy is unique because it uses music to help reduce stress, anxiety, and improve mood, which can be particularly beneficial for cancer patients. Unlike traditional medical treatments, it involves active or passive participation in music sessions led by a trained therapist, focusing on emotional and psychological support rather than directly targeting the cancer itself. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment for stress reduction in ovarian cancer patients?

Research shows that music therapy, a component of the treatment, can effectively reduce stress, anxiety, and pain in cancer patients, improving their mood and overall well-being during treatment. ^{4 6 8 9 11}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Guided imagery and music: using the Bonny method to evoke emotion and access the unconscious. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Music therapy: a valuable adjunct in the oncology setting. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Music therapy research and applications in pediatric oncology treatment. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Music therapy for mood disturbance during hospitalization for autologous stem cell transplantation: a randomized controlled trial. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Music therapy and internal medicine]. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Music therapy for dementia symptoms. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Integrative Music Therapy: A Healing Intervention. [2019]

9. Bulgaria pubmed.ncbi.nlm.nih.gov

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

10. Brazil pubmed.ncbi.nlm.nih.gov

Interactive Music Therapy on Stress Level Reduction in Women Submitted to IVF/ICSI. Prospective Randomized Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. [2023]