Breast Cancer, Radiation Therapy
Conditions
Brief summary
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
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.
Interventions
DEVICEGroup wearing a radiotherapy bra
Group wearing a radiotherapy bra
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective
Intervention model description
Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically confirmed invasive breast cancer or ductal carcinoma in situ 2. Patients eligible for whole breast irradiation after partial mastectomy 3. Adults over 20 years old 4. Patients with good overall performance (ECOG PS 0-1)
Exclusion criteria
1. Recurrent breast cancer patients 2. Patients who have previously received radiation therapy to the ipsilateral breast 3. Patients who underwent breast reconstruction 4. Bilateral breast cancer 5. Patients with skin diseases such as contact dermatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra | During the radiotherapy, an average of 1 month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation dosimetric evaluation | at the time of completion of radiotherapy | radiation dose to lungs, heart and breast |
| Patient satisfaction assessment | at the time of completion of radiotherapy | 1. Survey on anxiety before and after radiation treatment (using STAI, APAIS, and LASA scales) 2. Survey on satisfaction with radiotherapy bra after radiation therapy |
| Assessment of treatment toxicity | at 6 months and 12 months after the radiotherapy | 1. Acute toxicity grade 2 or higher according to CTCAE version 5.0 2. Late toxicity grade 2 or higher according to CTCAE version 5.0 |
Countries
South Korea
Outcome results
None listed