Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

February 4, 2025 updated by: Hwa Kyung Byun, Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group wearing a bra
Patients wear a bra while receiving radiotherapy.
Device: Group wearing a radiotherapy bra
Group wearing a radiotherapy bra
No Intervention: Group not wearing a bra
Patients do not wear a bra while receiving radiotherapy.

What is the study measuring?

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
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
During the radiotherapy, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation dosimetric evaluation
Time Frame: at the time of completion of radiotherapy
radiation dose to lungs, heart and breast
at the time of completion of radiotherapy
Patient satisfaction assessment
Time Frame: 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
at the time of completion of radiotherapy
Assessment of treatment toxicity
Time Frame: 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
at 6 months and 12 months after the radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hwakyung BYUN, professor, Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

November 13, 2023

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2023-0052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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