Respiratory Training and Relaxation Techniques to Improve Adjuvant Radiation Therapy in DIBH in Breast Cancer Patients - B-REST-Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this prospective clinical trial is to improve patient compliance and performance of deep inspiration breath hold (DIBH) to further reduce the cardiac dose from left breast radiation, and to improve cooperation and patient satisfaction through an active and formal pre-treatment respiratory training program combined with relaxation training (R\&R) in breast cancer patients undergoing adjuvant radiotherapy for left sided breast cancer. The main questions the study aims to answer are: * Does the use of communication training and the use of relaxation techniques (R\&R) reduce the Maximum dose to the heart (Dmax) and improve further heart dose parameters in deep inspiration during adjuvant radiotherapy for breast cancer? * Does R\&R improve longitudinal anxiety and quality of life under patients undergoing DIBH adjuvant radiotherapy for left sided breast cancer? Participants will be randomly assigned to either an experimental arm, which will receive the R\&R, versus a standard arm that will not receive the R\&R. * training program in the experimental arm includes breath hold training, music, and nature sounds that patients can listen to on an MP3 player * both groups complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up Researchers will compare the R\&R group (interventional arm) to current conventional DIBH instruction (standard group) to see if Dmax to the heart decreases and compliance and satisfaction under patients rises.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female breast cancer patients

• Left sided breast cancer

• Treated with surgery prior to radiotherapy

• Age \>18 years at time of inclusion

• WHO performance status 0-1

• Planned for radiotherapy alone to the breast, the chest wall and/or the lymph node areas

• Radiotherapy based on planning-CT scan using either 3D-CRT, IMRT, or VMAT/RapidArc

• Written Informed consent

Locations
Other Locations
Germany
Department of Radiation Oncology, Technical University of Munich
RECRUITING
Munich
Contact Information
Primary
Kai Borm, MD
kai.borm@mri.tum.de
0049-89-4140-4501
Backup
Rebecca Asadpour, MD
rebecca.asadpour@mri.tum.de
0049-89-4140-4501
Time Frame
Start Date: 2022-06-22
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 108
Treatments
Experimental: R&R arm (interventional arm)
The training program in the experimental arm includes relaxation techniques, breath hold training, music, and nature sounds that patients can listen to on an MP3 player. The training is offered one week before the planning CT scan and patients are encouraged to practice independently. Patients complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up.
No_intervention: Standard arm
Patients in the standard arm receive current conventional DIBH instruction without an extended R\&R training. Patients complete standardized questionnaires about their well-being and satisfaction at prospective time points before, during the radiation treatment course, as well as at 6 weeks follow-up.
Related Therapeutic Areas
Sponsors
Leads: Technical University of Munich
Collaborators: German Cancer Aid

This content was sourced from clinicaltrials.gov