Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-10-20

Brief Summary

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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.

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Detailed Description

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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

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Breast Cancer Radiation Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Group wearing a bra

Patients wear a bra while receiving radiotherapy.

Group Type EXPERIMENTAL

Group wearing a radiotherapy bra

Intervention Type DEVICE

Group wearing a radiotherapy bra

Group not wearing a bra

Patients do not wear a bra while receiving radiotherapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Group wearing a radiotherapy bra

Intervention Type DEVICE

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No