Stochastic Modulated Vibrations on Autonomic Nervous System of Breast Cancer Patients During Radiotherapy

Study Overview
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Brief Summary
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The aim of this research is to study the influence of stochastic modulated vibrations on the autonomic nervous system of breast cancer patients during radiation therapy

Detailed Description
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Since it is well known that breast cancer patients experience an important load of stress from diagnosis through treatment and throughout cancer survivorship (fear of cancer recurrence), this study focusses on activation the parasympathetic nervous system and making patients as comfortable as possible during treatment. The scope of this study is based on previous research, that has shown that controlling physical and psychological complications during treatment may have a positive (preventive) effect on late term and long-term quality of life and survival outcomes. Breast cancer patients will receive andullation during their irradiation period. The primary outcome measure of the autonomic nervous system is vagal nerve activity, a modulator of the parasympathetic nervous system. Secondary outcome measures are stress, pain and lymphedema.

Official Title
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The Influence of Stochastic Modulated Vibrations on the Autonomic Nervous System of Breast Cancer Patients During Radiotherapy: a Randomized Clinical Trial

Conditions
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Autonomic Nervous System Imbalance, Psychological Distress, Cancer-related Pain, Breast Cancer Lymphedema, Quality of Life

Intervention / Treatment
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* Device: Andullation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological proven breast cancer, following breast cancer surgery Starting with adjuvant radiation therapy for 3 weeks Minimum 18 years Medical record available and complete Supine lying on mattress for 20 minutes is possible Dutch, French or English Exclusion Criteria: Severe neurological, orthopaedic or rheumatic disorders Cardiac disorders Early or synchronous malignancy Pregnancy or lactation Persons suffering from depression or illnesses which influence the mental health or wellbeing

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>A 3 week intervention with Andullation will be performed, 3 times a week for 20 minutes after completion of the radiotherapy session | Device: Andullation<br>* Andullation is a horizontal vibration technique with stochastically modulated vibrations, build-in in a mattress.<br>|
| Placebo Comparator: Control<br>This group will follow the same intervention protocol, but without the application of the Andullation technology | Other: Placebo<br>* Placebo Andullation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Heart Rate Variability (HRV) | a marker of the activity of your autonomic nervous system. | through study completion, an average of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Distress Thermometer | A questionnaire to evaluate in what extent you experience complaints like distress and anxiety, on a visual thermometer. By encircling the number most applicable for your situation, we can estimate how you are feeling at the moment. The scale ranges from 0-10 where 0 indicates a better and 10 indicates a worse outcome. | through study completion, an average of 6 weeks | 
| change in Brief Pain Inventory | This questionnaire was designed to investigate the extent of pain you experience as well as to examine the influence of it on your quality of life. The BPI includes four ratings of pain intensity (items 3-7), and seven other ratings on the impact of pain. Intensity is recorded on numerical scales from zero (no pain) to ten (pain as bad as you can imagine). Also, intensity is rated at the time of completing the questionnaires (pain now) as well as its worst, least, and average over the past day or week. | through study completion, an average of 6 weeks | 
| change in Numeric Pain Rating Scale | An 11-point scale for patient self-reporting of pain. The scale ranges from 0-10 where 0 indicates a better and 10 indicates a worse outcome. | through study completion, an average of 6 weeks | 
| change in Perometer results | A device measuring your arm circumferences with the use of infrared light. It is an efficient, safe, painless and reliable method to examine your arm circumferences. | through study completion, an average of 6 weeks | 
| change in Bioimpedance spectroscopy | By using bioimpedance, we will estimate your body fat, water and muscle content. You will stand on scale and hold on to a handgrip that is connected with the scale. A small current will determine your body composition. This is a painless and innocuous examination. | through study completion, an average of 6 weeks | 
| change in European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30) | A questionnaire designed to investigate the quality of life in cancer patients. The questionnaire assesses some domains of your quality of life that can possibly be influenced by your disease. The questionnaire consists of 3 different scales: Global Health Status (GHS), Functional Scale (FS) and Symptom Scale (SS). The answers of the FS and SS are scored on a Likert scale where lower scores indicate better outcomes.The GHS differs from the other scales by scoring on a 7-point Likert scale where lower scores display worse outcomes. | through study completion, an average of 6 weeks | 
| change in European Organization for Research and Treatment of Cancer 23-item quality of life questionnaire (EORTC QLQ BR23) | A questionnaire designed to investigate the quality of life in breast cancer patients. The questionnaire assesses some domains of your quality of life that can possibly be influenced by your disease. It consists of 23 questions to determine body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss assessed on a 4 point Likert scale where lower scores indicate better outcomes. | through study completion, an average of 6 weeks | 
| change in Pittsburgh Sleep Quality Index | A questionnaire that assesses your sleep quality, your sleep quantity and your sleep disturbance. The scale ranges from 0-21 where lower scores indicate better outcomes | through study completion, an average of 6 weeks | 
| change in Insomnia Severity Index | A questionnaire that assesses the severity, the nature and the impact of your insomnia over the past 2 - 4 weeks. The scale ranges from 0-28 where lower scores indicate better outcomes. | through study completion, an average of 6 weeks |