Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yonsei University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra
Study Overview
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.
Study Design
- Study Type
- Interventional
- 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
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group wearing a bra
Patients wear a bra while receiving radiotherapy.
Intervention: Group wearing a radiotherapy bra (Device)
Group not wearing a bra
Patients do not wear a bra while receiving radiotherapy.
Outcomes
Primary Outcomes
The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra
Time Frame: 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 Outcomes
- Radiation dosimetric evaluation(at the time of completion of radiotherapy)
- Patient satisfaction assessment(at the time of completion of radiotherapy)
- Assessment of treatment toxicity(at 6 months and 12 months after the radiotherapy)
Investigators
Hwa Kyung Byun
professor
Yonsei University