Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

NCT06178861 | Completed

• 1 other identifier: 9-2023-0052
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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

  During the radiotherapy, an average of 1 month

Secondary Outcomes (3)

• 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

Study Arms (2)

Group wearing a bra

EXPERIMENTAL

Patients wear a bra while receiving radiotherapy.

Device: Group wearing a radiotherapy bra

Group not wearing a bra

NO INTERVENTION

Patients do not wear a bra while receiving radiotherapy.

Interventions

Group wearing a radiotherapy bra DEVICE

Group wearing a radiotherapy bra

Group wearing a bra

Eligibility Criteria

• Gender Eligibility Details: breast cancer
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yongin Severance Hospital

Yongin-si, 365, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39952437 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hwakyung BYUN, professor

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Test group: Group wearing a radiotherapy bra / Control group: Group not wearing a radiotherapy bra -Allocation: Random -Blinding: None -Time: Prospective

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 21, 2023
• Study Start: December 1, 2022
• Primary Completion: November 13, 2023
• Study Completion: October 20, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)