RadiotherapyB-RESTNCT05975190
Respiratory Training and Relaxation Techniques to Improve Adjuvant Radiation Therapy in DIBH in Breast Cancer
A study testing Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer in people with Radiotherapy and Breast Cancer, run by Technical University of Munich at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Radiotherapy, Breast Cancer, Relaxation
- What is being tested?
- Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jun 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Pregnancy, Breastfeeding
- Previous thoracic or mediastinal radiation
- Bilateral breast cancer
- Partial breast irradiation
- M1 disease (metastatic breast cancer)
- Severe lung disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Technical University of Munich
Munich, 81675
Kai Borm, MD, 0049-89-4140-4501, kai.borm@mri.tum.de
Rebecca Asadpour, MD, 0049-89-4140-4501, rebecca.asadpour@mri.tum.de
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Radiotherapy, Breast Cancer, Relaxation, Breathholding
- Being tested
- Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer
- Keywords
- Adjuvant radiotherapy for Breast Cancer, DIBH in left sided Breast Cancer, Respiratory and Relaxation Techniques, patients compliance, active participation under radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancerOther
R\&R training provided on an MP3-player for daily practice
| Study group | Role | What they receive |
|---|---|---|
| R&R arm (interventional arm) | Experimental | 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. Receives: Other: Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer |
| Standard arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during treatment (4 weeks)
Secondary outcomes (8)
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)
Measured: - 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
Measured: 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
Measured: during treatment (4 weeks)
Improving LAD Dmax under radiotherapy of left sided breast cancer
Change in LAD Dmax as a measure of cardiac toxicity
Measured: 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
Measured: 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.
Measured: - 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)
Measured: - 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
Measured: during treatment (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start22 Jun 2022
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomized design of the study will test R\&R interventions compared to current conventional DIBH instruction.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Cancer Aid
- Responsible party
- Sponsor
- Investigators
- Stephanie Combs, MD, Principal investigator, Department of Radiation Oncology, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975190
- Sponsor's protocol ID
- 2020-277_1-S-NP
- Acronym
- B-REST
- Status last verified
- Jan 2023
- First submitted
- 12 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Training and Relaxation Techniques to Improve Adjuvant Radiation Therapy in DIBH in Breast Cancer Patients - B-REST-Study
- ClinicalTrials.gov ID
- NCT05975190
- Acronym / sponsor ID
- B-REST / 2020-277_1-S-NP
- Conditions
- Radiotherapy, Breast Cancer, Relaxation, Breathholding
- Keywords
- Adjuvant radiotherapy for Breast Cancer, DIBH in left sided Breast Cancer, Respiratory and Relaxation Techniques, patients compliance, active participation under radiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Cancer Aid
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomized design of the study will test R\&R interventions compared to current conventional DIBH instruction.
| Arm | Type | Receives |
|---|---|---|
| R&R arm (interventional arm) | Experimental | Other: Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancerThe 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. |
| Standard arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- Age <18 years
- Pregnancy, Breastfeeding
- Previous thoracic or mediastinal radiation
- Bilateral breast cancer
- Partial breast irradiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancerR\&R training provided on an MP3-player for daily practice | Other | R&R arm (interventional arm) |
Primary outcome
Change of Dmax to the heart in DIBH under adjuvant radiotherapy of left sided breast cancer
Time frame: during treatment (4 weeks)
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
8 secondary outcomes
Improving quality of life under radiotherapy of left sided breast cancer
Time frame: - at baseline - during treatment (4 weeks) - at 6 week Follow-Up
Improving heart Dmean under radiotherapy of left sided breast cancer
Time frame: during treatment (4 weeks)
Improving Left anterior descending (LAD) Dmean under radiotherapy of left sided breast cancer
Time frame: during treatment (4 weeks)
Improving LAD Dmax under radiotherapy of left sided breast cancer
Time frame: during treatment (4 weeks)
Improving left ventricle (LV) Dmean under radiotherapy of left sided breast cancer
Time frame: during treatment (4 weeks)
Evaluation of clinic workflow metrics under radiotherapy of left sided breast cancer
Time frame: - 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
Time frame: - during treatment (4 weeks) - at 6 week Follow-Up
Improving radiation dose in organs at risk under radiotherapy of left sided breast cancer
Time frame: during treatment (4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Combs, MD principal investigator
Department of Radiation Oncology, Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory training and relaxation techniques under adjuvant radiation therapy in DIBH in breast cancer in people with Radiotherapy and Breast Cancer, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Borm, MD (0049-89-4140-4501, kai.borm@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Dmax to the heart in DIBH under adjuvant radiotherapy of left sided breast cancer (time frame: during treatment (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.