Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

Study Overview
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Brief Summary
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This prospective randomized study investigated the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity when wearing and not wearing a bra during radiotherapy for patients with breast cancer.

Detailed Description
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Post-surgery radiotherapy to the breast is standard treatment after breast-conserving surgery in patients with breast cancer. In order to apply the latest radiation therapy technologies, such as intensity-modulated radiotherapy, it is important to maintain the correct posture. However, due to the nature of the breast made of soft tissue, it is difficult to maintain the same breast shape during each treatment. This is especially difficult for large, ptotic breasts. Accordingly, we developed a bra for breast cancer patients in order to perform accurate radiotherapy. It was designed to fix the breast using bands in various directions so that its shape and position can be fixed during radiation treatment. This is a prospective, randomized controlled study to evaluate the effects of using a bra for breast cancer patients on the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity.

Official Title
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Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

Conditions
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Breast Cancer, Radiation Therapy

Intervention / Treatment
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* Device: Group wearing a radiotherapy bra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed invasive breast cancer or ductal carcinoma in situ Patients eligible for whole breast irradiation after partial mastectomy Adults over 20 years old Patients with good overall performance (ECOG PS 0-1) Exclusion Criteria: Recurrent breast cancer patients Patients who have previously received radiation therapy to the ipsilateral breast Patients who underwent breast reconstruction Bilateral breast cancer Patients with skin diseases such as contact dermatitis
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group wearing a bra<br>Patients wear a bra while receiving radiotherapy. | Device: Group wearing a radiotherapy bra<br>* Group wearing a radiotherapy bra<br>|
| No Intervention: Group not wearing a bra<br>Patients do not wear a bra while receiving radiotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra | Evaluating the reproducibility of breast shape through cross-correlation values in cone-beam CT and planning CT matching. This study involves comparing groups of patients wearing and not wearing a bra | During the radiotherapy, an average of 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dosimetric evaluation | radiation dose to lungs, heart and breast | at the time of completion of radiotherapy | 
| Patient satisfaction assessment | Survey on anxiety before and after radiation treatment (using STAI, APAIS, and LASA scales) Survey on satisfaction with radiotherapy bra after radiation therapy | at the time of completion of radiotherapy | 
| Assessment of treatment toxicity | Acute toxicity grade 2 or higher according to CTCAE version 5.0 Late toxicity grade 2 or higher according to CTCAE version 5.0 | at 6 months and 12 months after the radiotherapy |