Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer (NCT06660628) | Clinical Trial Compass
RecruitingNot Applicable
Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer
China348 participantsStarted 2024-08-21
Plain-language summary
The study is a single-center, prospective, non-randomized controlled study. The primary objective is to examine the clinical outcomes of utilizing Deep Inspiration Breath Hold (DIBH) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its potential to reduce the incidence of cardiac-related clinical and subclinical events.Participants will revieve large segmentation sadiotherapy ± DIBH for left breast cancer and be followed up to gather their clinical cardiac imformation.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. 18-70 years old, female, life expectancy \> 5 years
✓. ECOG 0, 1, 2 points
✓. Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy
✓. The patient will receive radiation therapy to the entire breast or chest wall ± the lymphatic drainage area above and below the clavicle ± the lymphatic drainage area in the axilla.
✓. No prior neoadjuvant chemotherapy or breast reconstruction.
✓. No active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline.
✓. Patients can hold their breath for at least 30 seconds after training
✓. Patients who can be followed up and agree to follow the plan.
Exclusion criteria
✕. Lesions were observed on both sides of the breast.
✕. Diagnosis could not be confirmed by pathology.
✕. Distant metastasis was identified.
✕. The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery.
✕. Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders
What they're measuring
1
Incidence of subclinical and clinical cardiac events
Timeframe: through study completion, an average of 1 year
✕. The patient's New York Heart Association (NYHA) cardiac classification is within categories 2-4.
✕. A history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (COPD) and interstitial pneumonia.