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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125953
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Nele, Universitair Ziekenhuis Brussel

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Autonomic Nervous System Imbalance Psychological Distress Cancer-related Pain Breast Cancer Lymphedema Quality of Life Device: Andullation Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Influence of Stochastic Modulated Vibrations on the Autonomic Nervous System of Breast Cancer Patients During Radiotherapy: a Randomized Clinical Trial
Actual Study Start Date : July 4, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. change in Heart Rate Variability (HRV) [ Time Frame: through study completion, an average of 6 weeks ]
    a marker of the activity of your autonomic nervous system.


Secondary Outcome Measures :
  1. change in Distress Thermometer [ Time Frame: through study completion, an average of 6 weeks ]
    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.

  2. change in Brief Pain Inventory [ Time Frame: through study completion, an average of 6 weeks ]
    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.

  3. change in Numeric Pain Rating Scale [ Time Frame: through study completion, an average of 6 weeks ]
    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.

  4. change in Perometer results [ Time Frame: through study completion, an average of 6 weeks ]
    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.

  5. change in Bioimpedance spectroscopy [ Time Frame: through study completion, an average of 6 weeks ]
    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.

  6. change in European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30) [ Time Frame: through study completion, an average of 6 weeks ]
    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.

  7. change in European Organization for Research and Treatment of Cancer 23-item quality of life questionnaire (EORTC QLQ BR23) [ Time Frame: through study completion, an average of 6 weeks ]
    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.

  8. change in Pittsburgh Sleep Quality Index [ Time Frame: through study completion, an average of 6 weeks ]
    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

  9. change in Insomnia Severity Index [ Time Frame: through study completion, an average of 6 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125953


Contacts
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Contact: Nele Adriaenssens, Prof. Dr. 00324763623 nele.adriaenssens@vub.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Nele Adriaenssens, prof. dr.    024763623 ext 0032    nele.adriaenssens@uzbrussel.be   
Sub-Investigator: Ellen Vandyck, dra.         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Nele Adriaenssens, Prof. Dr. Universitair Ziekenhuis Brussel
  Study Documents (Full-Text)

Documents provided by Nele, Universitair Ziekenhuis Brussel:

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Responsible Party: Nele, principal investigator, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04125953    
Other Study ID Numbers: 2018/455
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Cancer Pain
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lymphatic Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Postoperative Complications
Pathologic Processes