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

NCT04125953 | Unknown

• 1 other identifier: 2018/455
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• change in Heart Rate Variability (HRV)

  a marker of the activity of your autonomic nervous system.

  through study completion, an average of 6 weeks

Secondary Outcomes (9)

• change in Distress Thermometer

  through study completion, an average of 6 weeks

• change in Brief Pain Inventory

  through study completion, an average of 6 weeks

• change in Numeric Pain Rating Scale

  through study completion, an average of 6 weeks

• change in Perometer results

  through study completion, an average of 6 weeks

• change in Bioimpedance spectroscopy

  through study completion, an average of 6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: Andullation

Control

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Andullation DEVICE

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

Intervention

Placebo OTHER

Placebo Andullation

Control

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Cancer Pain; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes

Study Officials

• Nele Adriaenssens, Prof. Dr.

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nele Adriaenssens, Prof. Dr.

CONTACT

00324763623; nele.adriaenssens@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: October 14, 2019
• Study Start: July 4, 2019
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2020
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)