UnknownNot Applicable

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

Belgium130 participantsStarted 2019-07-04

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in Heart Rate Variability (HRV)

Timeframe: through study completion, an average of 6 weeks

Trial details

NCT IDNCT04125953

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09-30

Contact for this trial

Nele Adriaenssens, Prof. Dr.

00324763623 nele.adriaenssens@vub.be

View on ClinicalTrials.gov More Autonomic Nervous System Imbalance trials