Autonomic Nervous System ImbalanceNCT04125953
Stochastic Modulated Vibrations on Autonomic Nervous System of Breast Cancer Patients During Radiotherapy
A study testing Andullation in people with Autonomic Nervous System Imbalance and Psychological Distress, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Autonomic Nervous System Imbalance, Psychological Distress, Cancer-related Pain
- What is being tested?
- Andullation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Jul 2019to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Nele Adriaenssens, prof. dr., 024763623 ext. 0032, nele.adriaenssens@uzbrussel.be
Ellen Vandyck, dra.
About this study
Official title: 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
Read the 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.
- Conditions
- Autonomic Nervous System Imbalance, Psychological Distress, Cancer-related Pain, Breast Cancer Lymphedema, Quality of Life
- Being tested
- Andullation, Placebo
- Medical subject headings
- Cancer Pain, Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndullationDevice
Andullation is a horizontal vibration technique with stochastically modulated vibrations, build-in in a mattress.
PlaceboOther
Placebo Andullation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A 3 week intervention with Andullation will be performed, 3 times a week for 20 minutes after completion of the radiotherapy session Receives: Device: Andullation |
| Control | Placebo comparator | This group will follow the same intervention protocol, but without the application of the Andullation technology Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Heart Rate Variability (HRV)
a marker of the activity of your autonomic nervous system.
Measured: through study completion, an average of 6 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start4 Jul 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System ImbalanceStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nele, Universitair Ziekenhuis Brussel
- Investigators
- Nele Adriaenssens, Prof. Dr., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125953
- Sponsor's protocol ID
- 2018/455
- Status last verified
- Oct 2019
- First submitted
- 24 Jun 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Stochastic Modulated Vibrations on the Autonomic Nervous System of Breast Cancer Patients During Radiotherapy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04125953
- Acronym / sponsor ID
- 2018/455
- Conditions
- Autonomic Nervous System Imbalance, Psychological Distress, Cancer-related Pain, Breast Cancer Lymphedema, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: AndullationA 3 week intervention with Andullation will be performed, 3 times a week for 20 minutes after completion of the radiotherapy session |
| Control | Placebo comparator | Other: PlaceboThis group will follow the same intervention protocol, but without the application of the Andullation technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndullationAndullation is a horizontal vibration technique with stochastically modulated vibrations, build-in in a mattress. | Device | Intervention |
| PlaceboPlacebo Andullation | Other | Control |
Primary outcome
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.
9 secondary outcomes
change in Distress Thermometer
Time frame: through study completion, an average of 6 weeks
change in Brief Pain Inventory
Time frame: through study completion, an average of 6 weeks
change in Numeric Pain Rating Scale
Time frame: through study completion, an average of 6 weeks
change in Perometer results
Time frame: through study completion, an average of 6 weeks
change in Bioimpedance spectroscopy
Time frame: 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)
Time frame: 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)
Time frame: through study completion, an average of 6 weeks
change in Pittsburgh Sleep Quality Index
Time frame: through study completion, an average of 6 weeks
change in Insomnia Severity Index
Time frame: through study completion, an average of 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nele Adriaenssens, Prof. Dr. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andullation in people with Autonomic Nervous System Imbalance and Psychological Distress, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nele Adriaenssens, Prof. Dr. (00324763623, nele.adriaenssens@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Heart Rate Variability (HRV) (time frame: through study completion, an average of 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019; AzTrials last refreshed its copy on 8 Nov 2026.