跳至主要内容
临床试验/NCT06902051
NCT06902051招募中不适用

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

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
86
试验地点
1
主要终点
Subclinical Cardiovascular Events- Left ventricular ejection fraction (LVEF)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Lateral Decubitus Position in Patients with Left Breast Ca

Experimental

干预措施: Lateral Decubitus position (Device)

Lateral Decubitus Position in Patients with Left Breast Ca

Experimental

干预措施: Lateral Decubitus device (Device)

Prone

No Intervention

结局指标

主要结局

Subclinical Cardiovascular Events- Left ventricular ejection fraction (LVEF)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: From study participation to the completion of the radiotherapy plan up to 2 years

mean heart dose

Major Cardiovascular Events

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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