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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiotherapy; Relaxation; Breathholding
• Intervention / Treatment: Other: Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer

Detailed Description

Postoperative radiotherapy is widely practiced and highly effective in enabling breast conserving therapy in early stage tumors, and decreasing recurrence while improving survival in patients with advanced-stage breast cancer, the most common cancer in women. However, these benefits of radiotherapy are associated with a long-term risk of cardiac morbidity and mortality in breast cancer survivors. The unintended cardiac radiation exposure due to the heart's proximity to the treatment target has been well recognized, particularly in left-sided breast cancer. Because there is no lowest "safe" threshold radiation dose level for radiation-induced cardiac complications, the dose to the heart must be kept as low as possible to reduce the complications risk.

Recent advances in high-precision 3D conformal and intensity-modulated radiotherapy techniques have enabled better protection of the heart. Treatment in deep inspiration breath hold (DIBH) is indispensable to realize these technological capabilities by taking advantage of the greater distance created between the radiotherapy target and the contralaterally and inferiorly displaced heart during deep inspiration. While many studies have demonstrated reduction of the heart dose with DIBH, challenges in decreasing heart dose to a minimum remain.

Radiotherapy in DIBH requires active and complex cooperation from the patient, and its success critically depends on how well patients are capable to perform the prolonged extended deep breathing maneuver on a repetitive basis every day during their weeks-long treatment course. Both the physical demands and profound anxiety and stress, which are highly prevalent in breast cancer patients, additionally interfere with patients' DIBH performance. Anxiety is well known to directly adversely affect breathing patterns, thereby challenging patients' ability to perform DIBH optimally.

Preliminary research explored the role of physical training and showed that targeted DIBH training improves patients' cooperation and the ease of the DIBH procedure, and reduces the radiation dose to the heart. However, while DIBH training regimens may improve patients' physical respiratory skill levels, they do not address their mental stress and anxiety. Relaxation techniques to alleviate anxiety and stress have been rarely used in complex radiotherapy procedures, particularly not in DIBH. Preliminary studies in diagnostic radiology procedures suggest that advanced communication and relaxation techniques, targeted to relieve anxiety and stress, improve patients' procedural performance, anxiety and comfort. The investigators hypothesize that implementing both, DIBH Respiratory Training and advanced communication and Relaxation Training (R&R), improve patients' DIBH performance skills and further reduce heart dose, while alleviating anxiety and stress and improving quality of life during and after radiation therapy.

The investigators propose to test this hypothesis in a clinical trial randomizing R&R vs. standard-of-care management in patients with radiotherapy in DIBH for left breast cancer. The investigators primary endpoint will assess heart dose (Dmax), and secondary endpoints include longitudinal anxiety and quality of life assessment and clinic workflow efficiency. The ultimate goal of this proposal is to develop a validated patient-centered training and integrative health regimen to further improve the success of advanced-technology-based cardiac dose reduction, and improve cardiac health in breast cancer survivors.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kai Borm, MD; Phone Number: 0049-89-4140-4501; Email: kai.borm@mri.tum.de
• Study Contact Backup: Name: Rebecca Asadpour, MD; Phone Number: 0049-89-4140-4501; Email: rebecca.asadpour@mri.tum.de

Study Locations

• Germany
  • Munich, Germany, 81675
    • Recruiting
    • Department of Radiation Oncology, Technical University of Munich
    • Contact: Kai Borm, MD; Phone Number: 0049-89-4140-4501; Email: kai.borm@mri.tum.de
    • Contact: Rebecca Asadpour, MD; Phone Number: 0049-89-4140-4501; Email: rebecca.asadpour@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age <18 years
• Pregnancy, Breastfeeding
• Previous thoracic or mediastinal radiation
• Bilateral breast cancer
• Partial breast irradiation
• M1 disease (metastatic breast cancer)
• Severe lung disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer; R&R training provided on an MP3-player for daily practice
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Dmax to the heart in DIBH under adjuvant radiotherapy of left sided breast cancer	Maximum Dose to the heart (Dmax) in deep inspiration during adjuvant radiotherapy for breast cancer in dependence of the use of communication training and the use of relaxation techniques	during treatment (4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving quality of life under radiotherapy of left sided breast cancer	Quality of life outcome measures using a standardized questionnaire including parts of EORTC- Quality of Life-C30 (high score for a functional scale or global health status represent a high level of functioning or a high QoL, a high score for a symptom scale represents a high level of problems; scale: 0 - 100)	- at baseline - during treatment (4 weeks) - at 6 week Follow-Up
Improving heart Dmean under radiotherapy of left sided breast cancer	Change in heart Dmean as a measure of cardiac toxicity	during treatment (4 weeks)
Improving Left anterior descending (LAD) Dmean under radiotherapy of left sided breast cancer	Change in LAD Dmean as a measure of cardiac toxicity	during treatment (4 weeks)
Improving LAD Dmax under radiotherapy of left sided breast cancer	Change in LAD Dmax as a measure of cardiac toxicity	during treatment (4 weeks)
Improving left ventricle (LV) Dmean under radiotherapy of left sided breast cancer	Change in LV Dmean as a measure of cardiac toxicity	during treatment (4 weeks)
Evaluation of clinic workflow metrics under radiotherapy of left sided breast cancer	Evaluation of clinic workflow metrics in the radiation oncology unit related to the implementation of DIBH by measuring specific data, such as total treatment time, in comparison with metrics of patients in the control group.	- before start of treatment (one week before planning CT) - during treatment (4 weeks) - at 6 week Follow-Up
Improving patients satisfaction with R&R under radiotherapy of left sided breast cancer	Patient-reported outcome measures using a standardized questionnaire including parts of EORTC-Qualitiy of Life-BR-23 (Breast Cancer score, higher scores mean a worse outcome; scale: 0-100)	- during treatment (4 weeks) - at 6 week Follow-Up
Improving radiation dose in organs at risk under radiotherapy of left sided breast cancer	Comparison of radiation doses in organs at risk of structures other than the heart as a criterion for sparing adjacent organs and structures	during treatment (4 weeks)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Collaborators: German Cancer Aid
• Investigators: Principal Investigator: Stephanie Combs, MD, Department of Radiation Oncology, Technical University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Adjuvant radiotherapy for Breast Cancer; DIBH in left sided Breast Cancer; Respiratory and Relaxation Techniques; patients compliance; active participation under radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020-277_1-S-NP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No