Clinical trial NCT06178861: Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy
Official title: Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Radiation Therapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 38
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra
timeFrame: During the radiotherapy, an average of 1 month
Secondary outcomes:
measure: Radiation dosimetric evaluation
timeFrame: at the time of completion of radiotherapy
measure: Patient satisfaction assessment
timeFrame: at the time of completion of radiotherapy
measure: Assessment of treatment toxicity
timeFrame: at 6 months and 12 months after the radiotherapy
Other outcomes:
Locations:
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Hwakyung BYUN, professor
role: PRINCIPAL_INVESTIGATOR
References: