An interventional study of Large Segmentation Radiotherapy and DIBH in Breast Cancer, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 348 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Exclusion Criteria:
Patients with left breast cancer treated with Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique
Radiation: Large Segmentation Radiotherapy · Device: DIBH · Device: Surface guided radiation therapy
Patients with left breast cancer treated with traditional laser alignment with free breathing treatment
Radiation: Large Segmentation Radiotherapy · Device: laser alignment · Behavioral: free breathing
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold
Deep Inspiration Breath Hold
The technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment.
Laser systems for virtual simulation and patient positioning in radiotherapy
Patients breathe calmly while radiotherapy instead of holding their breath.
Incidence of subclinical and clinical cardiac events
1. Clinical events: newly emerged cardiac diseases after radiotherapy include acute and delayed pericarditis, pericardial effusion and constrictive pericarditis, coronary artery disease, myocardial infarction, cardiac valve disease and arrhythmia. 2. Subclinical events: new electrocardiogram (ECG) abnormalities, echocardiographic abnormalities, and abnormal elevations of cardiac enzymes after radiotherapy.
Time frame: through study completion, an average of 1 year
Survival
Localized regional control rate ,overall survival and disease-related survival.
Time frame: through study completion, an average of 1 year
Cosmetic results
cosmetic evaluation(breast-conserving surgery). Excellent: The treated mammary gland is indistinguishable or only slightly different in size, shape, and texture from the contralateral mammary gland. There may be mild thickening of the breast or skin, or scar tissue, but not enough to change the appearance of the colored gland. Good: The treated breast is not mildly asymmetric in size or shape compared to the contralateral breast. Thickening or scar tissue in the breast causes only Fair: The treated breast is significantly different in size and shape from the contralateral breast. Such changes involving 1/4 or less of the treated breast are significantly different in appearance from the contralateral breast. The change involves more than 1/4 of the breast tissue. Poor: The treated breast is significantly different in appearance from the contralateral breast. The change involves more than 1/4 of the breast tissue or the treated breast has severe sequelae.
Time frame: through study completion, an average of 1 year
Life quality
Assessment of patient quality of life by EORTC QLQ-BR23 , a higher score means worse life quality.
Time frame: through study completion, an average of 1 year
Plan to share: Yes
Supporting information: Study protocol
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Peking Union Medical College Hospital