Skip to main content
OpenTrials
Completed

NCT Number: NCT06178861

Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yongin Severance Hospital

Yongin-si, 365, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group wearing a radiotherapy bra

Device

Group wearing a radiotherapy bra

Primary outcomes

  1. 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

  1. Radiation dosimetric evaluation

    Time frame: at the time of completion of radiotherapy

    radiation dose to lungs, heart and breast

  2. Patient satisfaction assessment

    Time frame: at the time of completion of radiotherapy

    • Survey on anxiety before and after radiation treatment (using STAI, APAIS, and LASA scales)
    • Survey on satisfaction with radiotherapy bra after radiation therapy
  3. Assessment of treatment toxicity

    Time frame: at 6 months and 12 months after the radiotherapy

    • Acute toxicity grade 2 or higher according to CTCAE version 5.0
    • Late toxicity grade 2 or higher according to CTCAE version 5.0

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 21, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.