Идёт набор NCT06902051

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

Без фазы С лечением Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Lateral Decubitus position, Lateral Decubitus device.
Кому может быть актуально: Состояния в реестре: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Базовые параметры: 18 лет — 70 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

Устройство Lateral Decubitus position
Lateral Decubitus position with a special device
Устройство Lateral Decubitus device
Lateral Decubitus postion with a special device

Первичные конечные точки

Radiotherapy Planning Dose-Volume Parameter -Volume of 5Gy heart dose [Срок оценки: From study participation to the completion of the radiotherapy plan up to 2 years]
Radiotherapy Planning Dose-Volume Parameter -Max dose of LAD [Срок оценки: From study participation to the completion of the radiotherapy plan up to 2 years]
Radiotherapy Planning Dose-Volume Parameter -mean heart dose [Срок оценки: From study participation to the completion of the radiotherapy plan up to 2 years]
Major Cardiovascular Events [Срок оценки: From the initiation of radiotherapy to 2 years after its completion.]
Subclinical Cardiovascular Events- Left ventricular ejection fraction (LVEF) [Срок оценки: From the initiation of radiotherapy to 2 years after its completion.]
Subclinical Cardiovascular Events- Left ventricular diastolic dysfunction [Срок оценки: From the initiation of radiotherapy to 2 years after its completion.]

Критерии участия

Критерии включения

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