Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer; Radiation Therapy
• Interventions: Device: Group wearing a radiotherapy bra

• Registration Number: NCT06178861
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-11-13
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21
• Study Completion: 2024-10-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 38

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group wearing a bra	Group wearing a radiotherapy bra	Patients wear a bra while receiving radiotherapy.

Primary Outcome Measures

Name	Time	Method
The reproducibility of breast shape through cross-correlation values, both with and without the use of a bra	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 Outcome Measures

Name	Time	Method
Radiation dosimetric evaluation	at the time of completion of radiotherapy	radiation dose to lungs, heart and breast
Patient satisfaction assessment	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
Assessment of treatment toxicity	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

Trial Locations

Locations (1)

Yongin Severance Hospital; 🇰🇷 Yongin-si, Korea, Republic of