Breast Cancer Early Stage Breast Cancer (Stage 1-3)LDPLBCNCT06902051
Study on the Use of Lateral Decubitus Position in Left Breast Cancer Patients Undergoing Adjuvant Radiotherapy
A study testing Lateral Decubitus position and Lateral Decubitus device in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Nanfang Hospital, Southern Medical University at 2 sites in China.
Trial summary
A Prospective Study on the Application of Lateral Decubitus Position in Patients with Left Breast Cancer Undergoing Adjuvant Radiotherapy Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Lateral Decubitus position and Lateral Decubitus device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesChina
- Study dates
- 14 Apr 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong Provinse, 510515
hongmei Wang, +86-20-62787695, hongmeiw18@163.com
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong Provinse, 510515
Hongmei Wang, 86-20-62787695, hongmeiw18@163.com
About this study
Official title: 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
Read the 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.
- Being tested
- Lateral Decubitus position, Lateral Decubitus device
- Keywords
- Breast Cancer, Radiotherapy, Heart protection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Decubitus positionDevice
Lateral Decubitus position with a special device
Lateral Decubitus deviceDevice
Lateral Decubitus postion with a special device
| Study group | Role | What they receive |
|---|---|---|
| Lateral Decubitus Position in Patients with Left Breast Ca | Experimental | Not described Receives: Device: Lateral Decubitus position; Device: Lateral Decubitus device |
| Prone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiotherapy Planning Dose-Volume Parameter -Volume of 5Gy heart dose
Volume of 5Gy heart dose
Measured: From study participation to the completion of the radiotherapy plan up to 2 years
Radiotherapy Planning Dose-Volume Parameter -Max dose of LAD
Max dose of LAD
Measured: From study participation to the completion of the radiotherapy plan up to 2 years
Radiotherapy Planning Dose-Volume Parameter -mean heart dose
mean heart dose
Measured: From study participation to the completion of the radiotherapy plan up to 2 years
Major Cardiovascular Events
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).
Measured: From the initiation of radiotherapy to 2 years after its completion.
Subclinical Cardiovascular Events- Left ventricular ejection fraction (LVEF)
Subclinical cardiovascular events include electrocardiographic abnormalities and echocardiographic abnormalities, such as:
- Left ventricular ejection fraction (LVEF) < 50% or a reduction of > 10%.
Measured: From the initiation of radiotherapy to 2 years after its completion.
Subclinical Cardiovascular Events- Left ventricular diastolic dysfunction
Subclinical cardiovascular events include electrocardiographic abnormalities and echocardiographic abnormalities, such as:
- Left ventricular diastolic dysfunction, meeting at least two of the following four criteria:
- Mean E/e' > 14 (E/e'-lateral wall > 13 or E/Em-septum > 15).
- e'-lateral wall < 10 or e'-septum < 7.
- Tricuspid regurgitation velocity > 2.8 m/s.
- Left atrial volume index > 34 mL/m².
Measured: From the initiation of radiotherapy to 2 years after its completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start14 Apr 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902051
- Sponsor's protocol ID
- NFEC-2024-663
- Acronym
- LDPLBC
- Status last verified
- May 2025
- First submitted
- 11 Feb 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Application of Lateral Decubitus Position in Patients With Left Breast Cancer Undergoing Adjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT06902051
- Acronym / sponsor ID
- LDPLBC / NFEC-2024-663
- Keywords
- Breast Cancer, Radiotherapy, Heart protection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateral Decubitus Position in Patients with Left Breast Ca | Experimental | Device: Lateral Decubitus position, Device: Lateral Decubitus device |
| Prone | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lateral Decubitus positionLateral Decubitus position with a special device | Device | Lateral Decubitus Position in Patients with Left Breast Ca |
| Lateral Decubitus deviceLateral Decubitus postion with a special device | Device | Lateral Decubitus Position in Patients with Left Breast Ca |
Primary outcome
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
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
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
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).
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%.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral Decubitus position and Lateral Decubitus device in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Nanfang Hospital, Southern Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hongmei Wang, phD (13189092896, hongmeiw18@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.