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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-04

Study Completion Date

2020-10-31

Brief Summary

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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

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Detailed Description

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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

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Autonomic Nervous System Imbalance Psychological Distress Cancer-related Pain Breast Cancer Lymphedema Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

A 3 week intervention with Andullation will be performed, 3 times a week for 20 minutes after completion of the radiotherapy session

Group Type EXPERIMENTAL

Andullation

Intervention Type DEVICE

Andullation is a horizontal vibration technique with stochastically modulated vibrations, build-in in a mattress.

Control

This group will follow the same intervention protocol, but without the application of the Andullation technology

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo Andullation

Interventions

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Andullation

Andullation is a horizontal vibration technique with stochastically modulated vibrations, build-in in a mattress.

Intervention Type DEVICE

Placebo

Placebo Andullation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No