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

Universitair Ziekenhuis Brussel

Status: Unknown

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

Treatments: Other: Placebo; Device: Andullation

Study type: Interventional

Funder types: Other

Identifiers

NCT04125953

2018/455

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

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

Treatment:

Device: Andullation

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo