Study on the Use of Lateral Decubitus Position in Left Breast Cancer Patients Undergoing Adjuvant Radiotherapy

Not Applicable

Recruiting

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

• Registration Number: NCT06902051
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

A Prospective Study on the Application of Lateral Decubitus Position in Patients with Left Breast Cancer Undergoing Adjuvant Radiotherapy

Detailed Description

This clinical study is a randomized, non-blind, single-center prospective clinical trial. It recruits patients with left breast cancer who are undergoing postoperative adjuvant radiotherapy. After signing the informed consent form, the clinical physician evaluates the patient's deep inspiration breath-hold (DIBH) ability and cooperation. Patients who meet the DIBH technical requirements will be randomly assigned to the DIBH supine radiotherapy group or the DIBH lateral decubitus radiotherapy group. Patients who do not meet the DIBH technical requirements will be randomly assigned to the free breathing (FB) supine radiotherapy group or the FB lateral decubitus position radiotherapy group. A total of 86 patients will be recruited. Patients who undergo lateral decubitus radiotherapy will undergo two positional fixation sessions, one in the lateral decubitus position and another one in the supine position. A CT scan will be performed in both positions. Patients using DIBH undergo scans in both FB and DIBH positions. The radiation oncologist will delineate the target area and organs at risk on the CT images, while the physicist will develop the intensity-modulated radiotherapy (IMRT) plan. After evaluating the two treatment plans, the best plan will be selected for treatment. Baseline evaluations will be completed before the radiotherapy, and follow-up evaluations will be conducted on the day of treatment completion, as well as at 3, 6, 12, 18, and 24 months after treatment. This study aims to explore the cardiac dose advantages of lateral decubitus radiotherapy in left breast cancer patients undergoing postoperative adjuvant radiotherapy. It also seeks to identify potential indicators for predicting early cardiac damage in breast cancer patients undergoing adjuvant radiotherapy. The study will effectively integrate multimodal, multidimensional feature information and multi-class models, designing a feedback mechanism to explore the risk factors associated with radiation-induced heart disease (RIHD) and predict the occurrence risk of RIHD in breast cancer patients receiving radiotherapy.

Study Timeline

• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-03-30
• Study Start: 2025-04-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-04-30
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Voluntary signing of the informed consent form
• Female patients aged 18-70 years
• Newly diagnosed left-sided breast cancer confirmed by histopathology
• No evidence of distant metastasis
• Undergoing modified radical mastectomy or breast-conserving surgery
• ECOG performance status of 0, 1, or 2
• Tolerance to radiotherapy
• Radiation field covering the entire left breast/chest wall ± regional lymphatic drainage area

Exclusion Criteria

• Bilateral breast cancer at diagnosis
• History of breast reconstruction or implant placement on the affected side
• Prior radiotherapy to the chest or supraclavicular region
• Patients deemed unsuitable for the study based on the investigator's judgment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subclinical Cardiovascular Events- Left ventricular ejection fraction (LVEF)	From the initiation of radiotherapy to 2 years after its completion.	Subclinical cardiovascular events include electrocardiographic abnormalities and echocardiographic abnormalities, such as: - Left ventricular ejection fraction (LVEF) \< 50% or a reduction of \> 10%.
Radiotherapy Planning Dose-Volume Parameter -Volume of 5Gy heart dose	From study participation to the completion of the radiotherapy plan up to 2 years	Volume of 5Gy heart dose
Radiotherapy Planning Dose-Volume Parameter -Max dose of LAD	From study participation to the completion of the radiotherapy plan up to 2 years	Max dose of LAD
Radiotherapy Planning Dose-Volume Parameter -mean heart dose	From study participation to the completion of the radiotherapy plan up to 2 years	mean heart dose
Major Cardiovascular Events	From the initiation of radiotherapy to 2 years after its completion.	Major cardiovascular events include death due to coronary artery disease or other cardiac diseases, myocardial infarction, coronary revascularization, or hospitalization due to a major cardiovascular event (such as heart failure, valvular disease, arrhythmia, unstable angina, or other significant cardiovascular conditions).
Subclinical Cardiovascular Events- Left ventricular diastolic dysfunction	From the initiation of radiotherapy to 2 years after its completion.	Subclinical cardiovascular events include electrocardiographic abnormalities and echocardiographic abnormalities, such as: - Left ventricular diastolic dysfunction, meeting at least two of the following four criteria: 1. Mean E/e' \> 14 (E/e'-lateral wall \> 13 or E/Em-septum \> 15).; 2. e'-lateral wall \< 10 or e'-septum \< 7.; 3. Tricuspid regurgitation velocity \> 2.8 m/s.; 4. Left atrial volume index \> 34 mL/m².

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong Provinse, China