Using Deep Inspiration Breath Hold with Radiotherapy for Left Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the clinical outcomes of combining Deep Inspiration Breath Hold (DIBH) with hypo-fractionated radiotherapy in patients with left-sided breast cancer. It aims to assess the potential of this approach to reduce cardiac-related events during treatment. Participants will receive large segmentation radiotherapy with or without DIBH and will be monitored for cardiac health over time. The study is non-randomized and conducted at a single center, focusing on a specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18-70 years old, female, life expectancy \> 5 years
2. ECOG 0, 1, 2 points
3. Pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy
4. 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.
5. No prior neoadjuvant chemotherapy or breast reconstruction.
6. No active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline.
7. Patients can hold their breath for at least 30 seconds after training
8. Patients who can be followed up and agree to follow the plan.
9. Sign the consent form.

Exclusion Criteria:

1. Lesions were observed on both sides of the breast.
2. Diagnosis could not be confirmed by pathology.
3. Distant metastasis was identified.
4. The patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery.
5. Severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders
6. The patient's New York Heart Association (NYHA) cardiac classification is within categories 2-4.
7. A history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (COPD) and interstitial pneumonia.
8. Previous mediastinal radiotherapy.
9. Previous or concurrent second primary malignant tumor (except skin cancer that is not a malignant black pigmented tumor, papillary/follicular carcinoma of the thyroid, carcinoma in situ of the cervix, and contralateral non-invasive breast cancer).
10. Irradiation of the lymphatic drainage area of the internal breast is required.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaorong Hou
• Email: hxr_pumch@163.com
• Phone: +86 13811963013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.