Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

Breast Cancer Clinical Trial

Official title:

Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06178861
• Other study ID #: 9-2023-0052
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: October 20, 2024

Study information

• Verified date: December 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: October 20, 2024
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiation Therapy

Intervention

Device:
• Group wearing a radiotherapy bra
Group wearing a radiotherapy bra

Locations

Country	Name	City	State
Korea, Republic of	Yongin Severance Hospital	Yongin-si

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiation dosimetric evaluation	radiation dose to lungs, heart and breast	at the time of completion of radiotherapy
Secondary	Patient satisfaction assessment	Survey on anxiety before and after radiation treatment (using STAI, APAIS, and LASA scales); Survey on satisfaction with radiotherapy bra after radiation therapy	at the time of completion of radiotherapy
Secondary	Assessment of treatment toxicity	Acute toxicity grade 2 or higher according to CTCAE version 5.0; Late toxicity grade 2 or higher according to CTCAE version 5.0	at 6 months and 12 months after the radiotherapy