Clinical trial NCT03511079: Music as a Perioperative Therapy in Breast Cancer Patients
Official title: Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: Music
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two groups. The intervention group will listen to music each night several days before and after surgery. The control group will not listen to music each night around the time of surgery.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Music has often been used in hospitals as a therapy but there is a limited amount of research looking at how music actually affects the different molecules in the body, such as cortisol (a marker of stress). There is especially a lack of research in the context of surgery. The hope is that this study will show that music can be used to minimize some of the side effects related to breast surgery and improve the patient experience.

Detailed description: In medical practice, an ideal therapy should have maximal benefit with minimal risk. While considerable effort is being placed into discovering more effective pharmaceuticals, there is a growing field of interest in alternative therapies. In the 1970's, George Engle put forward the idea of the biopsychosocial response in which the patient's social and psychological factors can influence the body's biologic function and vice versa. One such potential therapy that could work by this mechanism is music. Advantages of music include low cost, availability, no required expertise, and minimal side effects. Studies have shown that music leads to reduced postoperative pain, anxiety, and analgesic needs in surgical patients. It has also been shown that patient selected music has greater outcomes than researcher selected music. While there is a significant body of literature on changes in clinical measurements, there are only two studies known to us which try to examine the effects of music on a molecular level, measuring cortisol and blood glucose respectively. Neither of these studies have been performed in patients undergoing surgery for breast cancer.

On the other hand, considerable research is currently being conducted to determine biomarkers in the context of surgery that are associated with poor outcomes, especially in the context of breast surgery. Stress, usually associated with cortisol levels, has been associated with increased sleep disruption, increased metabolism, increased risk of thromboembolic events, and impaired wound healing in patients. In breast cancer patients, it has been found that C-reactive protein levels correlated in fatigue postoperatively and decreased diurnal variation in cortisol has been associated with depression. Melatonin, in general, is a marker for circadian rhythm and would also be representative of sleep disruption. C-reactive protein is primarily a marker of inflammation which in turn is associated with disease progression and poorer clinical outcomes in breast surgery patients.

This study aims to determine both if music affects molecular mechanisms through measurement of clinical biomarkers as well as if there is an association with significant quality of life measures. A positive association could provide evidence into music being used as an adjunct therapy peri-operatively.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stage 0 to stage III breast cancer as classified by the American Joint Committee on Cancer
* Undergoing a mastectomy or lumpectomy at Penn State Hershey Medical Center
* Fluent in written and spoken English

Exclusion Criteria:

* Hearing loss or other difficulties hearing that, in the opinion of the research team, prevent the subject from listening to music
* Serious oral health or dental conditions that affect saliva production
* Patients who have undergone pre-operative chemotherapy or pre-operative radiation therapy
* Should not be taking supplements of melatonin or taking corticosteroids
* History of liver cancer
* History of liver disease or cirrhosis (based on MELD score)
* History of endocrine tumors
* Lack of electronic device (smartphone, computer, etc) on which to listen to music
* Cognitive impairment
* Prisoner

Primary outcomes:
measure: Change in Pain
timeFrame: The survey will be given three days prior to surgery and seven days after surgery.
measure: Change in Sleep Quality
timeFrame: The scale will given three days prior to surgery and seven days after surgery.
measure: Change in Depression
timeFrame: The questionnaire will be given three days prior to surgery and seven days after surgery.
Secondary outcomes:
measure: Change in Salivary Cortisol level
timeFrame: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
measure: Change in Salivary Melatonin level
timeFrame: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
measure: Change in Salivary C-reactive protein level
timeFrame: Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Breast Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kristine L Widders, MD
role: PRINCIPAL_INVESTIGATOR
References:
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