Trials / Unknown
UnknownNCT04125953
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Universitair Ziekenhuis Brussel · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Andullation | Andullation is a horizontal vibration technique with stochastically modulated vibrations, build-in in a mattress. |
| OTHER | Placebo | Placebo Andullation |
Timeline
- Start date
- 2019-07-04
- Primary completion
- 2020-09-30
- Completion
- 2020-10-31
- First posted
- 2019-10-14
- Last updated
- 2019-10-14
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT04125953. Inclusion in this directory is not an endorsement.