Nature Sounds for Breast Cancer

Overseen By Cancer Clinical Trials Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Chicago

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients will be randomly assigned to one of two groups: the group exposed to NS, or the standard care group exposed to supportive dialogue. Patients assigned to the former group will be exposed to continuous NS throughout the CNB procedure.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Nature Sounds for breast cancer?

Research on music interventions, which are similar to nature sounds, shows they can improve quality of life, reduce anxiety and depression, and lessen chemotherapy side effects like vomiting in breast cancer patients. ^{1 2 3 4 5}

Is listening to nature sounds safe for breast cancer patients?

There is no specific safety data on listening to nature sounds for breast cancer patients, but general concerns about 'natural' therapies include potential interactions with medications and adverse effects from high consumption levels. It's important for patients to discuss any complementary treatments with their doctors to ensure safety. ^{6 7 8 9 10}

How does the 'Nature Sounds for Breast Cancer' treatment differ from other treatments for breast cancer?

The 'Nature Sounds for Breast Cancer' treatment is unique because it uses sound as a complementary therapy to improve the emotional and physical well-being of cancer patients, unlike traditional treatments that focus on directly targeting the cancer itself. This approach is similar to music therapy, which has been shown to reduce anxiety, depression, and improve quality of life in breast cancer patients. ^{3 5 11 12 13}

Research Team

Kirti Kulkarni, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for individuals aged 21 or older who are undergoing a breast core biopsy (CNB) and can read and speak English. Participants must provide written consent to join the study.

Inclusion Criteria

To be able to read and speak English

Provide written informed consent.

I am 21 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Participants undergo a core needle biopsy (CNB) procedure with either nature sounds or supportive dialogue

30-45 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2 years

Treatment Details

Interventions

• Nature Sounds

Trial Overview The study is testing if listening to nature sounds (NS) during CNB can help reduce pain and anxiety compared to standard care, which involves supportive dialogue. Patients will be randomly placed in either the NS group or the standard care group.

Participant Groups

Group I: Nature sounds exposure Experimental Treatment 1 Intervention

Patients will be randomly assigned to either the nature sounds group or the standard care group. Patients in the nature sounds group will be exposed to continuous nature sounds during the core needle biopsy (CNB) procedure. The CNB procedure will continue as planned with nature sounds playing instead of the supportive dialogue. All sounds will be played out of a speaker situated in the corner of the room.

Group II: Standard care (supportive dialogue) Active Control 1 Intervention

Patients will be randomly assigned to either the nature sounds group or the standard care group. The CNB procedure will continue as planned with supportive dialogue which will be played out of a speaker situated in the corner of the room. This group follows the current standard of care.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

In a randomized clinical trial involving breast cancer patients undergoing chemotherapy, a 30-minute music intervention before treatment significantly improved quality of life scores compared to a control group.

The music group also experienced lower levels of depression and anxiety, as well as reduced incidence of vomiting during chemotherapy, indicating that music can be an effective complementary therapy to alleviate some adverse effects of cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. Lima, TU., Moura, ECR., Oliveira, CMB., et al.[2021]

A review of 76 studies involving 92 cancer patients revealed that 87% of adverse events (AEs) from health food (HF) intake were due to the foods themselves, with 70% of identified cases being severe (grades 3 to 5).

Common severe AEs included hepatic and respiratory disorders, particularly in Japanese patients, and notable issues like hypercalcemia and bacterial infections were linked to specific health food products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic Review of Case Reports on the Adverse Events Due to Health Food Intake by Cancer Patients]. Kojima, A., Sato, Y., Nishijima, C., et al.[2020]

In a clinical trial involving 120 female breast cancer patients, music therapy significantly reduced state anxiety levels compared to routine nursing care alone, with lower anxiety scores observed at three different post-test measurements.

The study demonstrated that music therapy can be an effective complementary intervention for managing anxiety in patients following radical mastectomy, highlighting its potential role in holistic cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. Li, XM., Zhou, KN., Yan, H., et al.[2022]

References

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

Does music exposure during chemotherapy improve quality of life in early breast cancer patients? A pilot study. [2015]

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

Barriers to Implementation of Music Listening Interventions for Cancer-Related Phenomena: A Mapping Review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Sound Intervention on Physical and Emotional Well-Being in Patients with Cancer: A Prospective Randomized Trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Music Intervention on the Physical and Mental Status of Patients with Breast Cancer: A Systematic Review and Meta-Analysis. [2022]

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

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting patterns of concomitant botanical dietary supplements with CYP3A4 interactive & CYP3A4 non-interactive anticancer drugs in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). [2019]

7. Japan pubmed.ncbi.nlm.nih.gov

[Systematic Review of Case Reports on the Adverse Events Due to Health Food Intake by Cancer Patients]. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Are herbal remedies and dietary supplements safe and effective for breast cancer patients? [2018]

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

Relief of symptoms, side effects, and psychological distress through use of complementary and alternative medicine in women with breast cancer. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Adverse effects of herbal medicines: an overview of systematic reviews. [2022]

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

Complementary medicine in palliative care and cancer symptom management. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Effects of music therapy on anxiety of patients with breast cancer after radical mastectomy: a randomized clinical trial. [2022]

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

Alternative and complementary treatment needs and experiences of women with breast cancer. [2018]