Special breathing and relaxation techniques to alleviate the side effects of breast radiation therapy
- Gender
- Women
- Age
- 18 years and older
- Trial type
- Interventional
- Line of therapy
- First line
- Phase
- —
What is this trial about?
When the left breast is treated with radiation as part of breast cancer treatment, the heart is also exposed to radiation, which can cause damage to the heart. Using a special breathing technique during radiation therapy can reduce the radiation dose to the heart. The goal of the B-REST study is to investigate whether performance of the breathing technique can be improved through special training prior to radiation therapy. Women aged 18 and older who have had surgery for left-sided breast cancer and are scheduled to undergo radiation therapy are eligible to participate in this study.
Detailed description
Breast cancer (mammary carcinoma) is a malignant disease of the breast gland tissue characterized by the uncontrolled proliferation of breast gland cells. Treatment depends on various factors, such as the patient’s overall health, the stage of the disease, the tumor’s growth rate (Ki-67 index), the presence of hormone receptors on the surface of tumor cells, and the increased expression of the HER2 receptor (HER2-positive).
Treatment for stage 1 through 3B breast cancer usually includes surgery. After surgery, radiation therapy is administered in some cases to kill any remaining cancer cells. In this procedure, radiation is delivered externally to the breast, which inevitably affects surrounding tissue as well—particularly the heart when radiation is administered to the left side. Ionizing radiation damages the cells it strikes. A special breathing technique called “Deep Inspiration Breath Hold”—which involves taking a deep breath and then holding it—can reduce the radiation exposure to the heart. This is because it increases the distance between the heart and the treatment area. However, this technique can be strenuous for patients and may cause stress or anxiety.
The goal of the B-REST study is to investigate whether the performance of the “Deep Inspiration Breath Hold” (DIBH) technique can be improved through special training and relaxation techniques practiced prior to radiation therapy. The primary endpoint is the measurement of radiation exposure to the heart. Study participants will be randomly assigned to two study arms. Group 1 will receive specialized training in relaxation techniques and breathing exercises one week before radiation therapy or the corresponding preliminary examinations to facilitate holding their breath for longer periods. These exercises are combined with music and nature sounds and are intended to be performed independently afterward. Patients in Group 2 receive standard instructions on breathing patterns during radiation therapy but no separate training. The radiation dose to the heart is measured after radiation therapy. In addition, patients in both groups will complete questionnaires regarding their satisfaction and well-being during the study treatment and six weeks after the completion of radiation therapy. The study is open-label, meaning that both the medical staff and the patient know which group they have been assigned to. The treatments and follow-up examinations take place over a period of about two months.
Women aged 18 and older with left-sided breast cancer who have completed surgery are eligible to participate in this study. A prerequisite is planned adjuvant radiation therapy.
Facts
- What condition: Left-sided breast cancer (mammary carcinoma)
- Cancer characteristics: Previous surgery on the left breast followed by radiation therapy
- What the study investigates: The effects of specific relaxation exercises on breathing technique during radiation therapy and the radiation dose delivered to the heart as a side effect
- Study objective: To reduce radiation exposure to the heart through the use of specific breathing techniques learned in advance
- Study duration: approx. 2 months
- Study characteristics: Randomized, open-label, 2-group intervention
Trial sites
1 trial site in Germany is listed.
Klinikum rechts der Isar der Technischen Universität München
Ismaninger Straße 22, 81675 München
Recruiting
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description is based on the public trial registry (NCT05975190) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.


