Breast CancerNCT06178861
Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy
A study testing Group wearing a radiotherapy bra in people with Breast Cancer and Radiation Therapy, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Radiation Therapy
- What is being tested?
- Group wearing a radiotherapy bra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2022to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Radiation Therapy
- Being tested
- Group wearing a radiotherapy bra
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group wearing a radiotherapy braDevice
Group wearing a radiotherapy bra
| Study group | Role | What they receive |
|---|---|---|
| Group wearing a bra | Experimental | Patients wear a bra while receiving radiotherapy. Receives: Device: Group wearing a radiotherapy bra |
| Group not wearing a bra | No intervention | Patients do not wear a bra while receiving radiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the radiotherapy, an average of 1 month
Secondary outcomes (3)
Radiation dosimetric evaluation
radiation dose to lungs, heart and breast
Measured: 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
Measured: 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
Measured: at 6 months and 12 months after the radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Dec 2022
- Primary completion13 Nov 2023
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hwa Kyung Byun, Yonsei University
- Investigators
- Hwakyung BYUN, professor, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178861
- Sponsor's protocol ID
- 9-2023-0052
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byun HK, Kim H, Son J, Cho Y, Kwon YJ, Kim DW, Lee H, Kim YB. Impact of bra application in breast cancer radiotherapy: A pilot prospective randomized trial. Radiother Oncol. 2025 May;206:110785. doi: 10.1016/j.radonc.2025.110785. Epub 2025 Feb 12.
PubMed 39952437
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy
- ClinicalTrials.gov ID
- NCT06178861
- Acronym / sponsor ID
- 9-2023-0052
- Conditions
- Breast Cancer, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective
| Arm | Type | Receives |
|---|---|---|
| Group wearing a bra | Experimental | Device: Group wearing a radiotherapy braPatients wear a bra while receiving radiotherapy. |
| Group not wearing a bra | No intervention | –Patients do not wear a bra while receiving radiotherapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group wearing a radiotherapy braGroup wearing a radiotherapy bra | Device | Group wearing a bra |
Primary outcome
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
3 secondary outcomes
Radiation dosimetric evaluation
Time frame: at the time of completion of radiotherapy
Patient satisfaction assessment
Time frame: at the time of completion of radiotherapy
Assessment of treatment toxicity
Time frame: at 6 months and 12 months after the radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Derived from this study: PubMed 39952437Byun HK, Kim H, Son J, Cho Y, Kwon YJ, Kim DW, Lee H, Kim YB. Impact of bra application in breast cancer radiotherapy: A pilot prospective randomized trial. Radiother Oncol. 2025 May;206:110785. doi: 10.1016/j.radonc.2025.110785. Epub 2025 Feb 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hwakyung BYUN, professor principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group wearing a radiotherapy bra in people with Breast Cancer and Radiation Therapy, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.