Clinical trial NCT04125953: Stochastic Modulated Vibrations on Autonomic Nervous System of Breast Cancer Patients During Radiotherapy
Official title: The Influence of Stochastic Modulated Vibrations on the Autonomic Nervous System of Breast Cancer Patients During Radiotherapy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autonomic Nervous System Imbalance
Psychological Distress
Cancer-related Pain
Breast Cancer Lymphedema
Quality of Life
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: change in Heart Rate Variability (HRV)
timeFrame: through study completion, an average of 6 weeks
Secondary outcomes:
measure: change in Distress Thermometer
timeFrame: through study completion, an average of 6 weeks
measure: change in Brief Pain Inventory
timeFrame: through study completion, an average of 6 weeks
measure: change in Numeric Pain Rating Scale
timeFrame: through study completion, an average of 6 weeks
measure: change in Perometer results
timeFrame: through study completion, an average of 6 weeks
measure: change in Bioimpedance spectroscopy
timeFrame: through study completion, an average of 6 weeks
measure: change in European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ C-30)
timeFrame: through study completion, an average of 6 weeks
measure: change in European Organization for Research and Treatment of Cancer 23-item quality of life questionnaire (EORTC QLQ BR23)
timeFrame: through study completion, an average of 6 weeks
measure: change in Pittsburgh Sleep Quality Index
timeFrame: through study completion, an average of 6 weeks
measure: change in Insomnia Severity Index
timeFrame: through study completion, an average of 6 weeks
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Nele Adriaenssens, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: