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

May 6, 2025 updated by: Nanfang Hospital, Southern Medical University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong Provinse
      • Guangzhou, Guangdong Provinse, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lateral Decubitus Position in Patients with Left Breast Ca
Device: Lateral Decubitus position
Lateral Decubitus position with a special device
Device: Lateral Decubitus device
Lateral Decubitus postion with a special device
No Intervention: Prone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2024-663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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