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

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

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

Study Overview

• Status: Unknown
• Conditions: Quality of Life; Psychological Distress; Breast Cancer Lymphedema; Autonomic Nervous System Imbalance; Cancer-related Pain
• Intervention / Treatment: Device: Andullation; Other: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nele Adriaenssens, Prof. Dr.; Phone Number: 00324763623; Email: nele.adriaenssens@vub.be

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Recruiting
      • Universitair Ziekenhuis Brussel
      • Contact: Nele Adriaenssens, prof. dr.; Phone Number: 0032 024763623; Email: nele.adriaenssens@uzbrussel.be
      • Sub-Investigator: Ellen Vandyck, dra.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Nele Adriaenssens, Prof. Dr., Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 4, 2019
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): October 31, 2020

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (ACTUAL): October 14, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Breast Neoplasms; Lymphedema; Cancer Pain; Breast Cancer Lymphedema
• Other Study ID Numbers: 2018/455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No