NCT06902051

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Apr 2025May 2028

First Submitted

Initial submission to the registry

February 11, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

February 11, 2025

Last Update Submit

May 6, 2025

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

Breast CancerRadiotherapyHeart protection

Outcome Measures

Primary Outcomes (6)

  • Radiotherapy Planning Dose-Volume Parameter -Volume of 5Gy heart dose

    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

    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

    mean heart dose

    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).

    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%.

    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: 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.

Study Arms (2)

Lateral Decubitus Position in Patients with Left Breast Ca

EXPERIMENTAL
Device: Lateral Decubitus positionDevice: Lateral Decubitus device

Prone

NO INTERVENTION

Interventions

Lateral Decubitus positionDEVICE

Lateral Decubitus position with a special device

Lateral Decubitus Position in Patients with Left Breast Ca
Lateral Decubitus deviceDEVICE

Lateral Decubitus postion with a special device

Lateral Decubitus Position in Patients with Left Breast Ca

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong Provinse, 510515, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong Provinse, 510515, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

hongmei Wang, phD

CONTACT

13189092896hongmeiw18@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

March 30, 2025

Study Start

April 14, 2025

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

May 11, 2025

Record last verified: 2025-05

Locations

CN(2)