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NCT Number: NCT06660628

Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Xiaorong Hou

CONTACT

[email protected]

+86 13811963013

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Sign the consent form.

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
  • 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.
  • Previous mediastinal radiotherapy.
  • 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).
  • Irradiation of the lymphatic drainage area of the internal breast is required.

Treatment and study plan

Large Segmentation Radiotherapy

Radiation

Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold

DIBH

Device

Deep Inspiration Breath Hold

Surface guided radiation therapy

Device

The technology uses modern 3D camera technology to help track and monitor patient movements during set-up and treatment.

laser alignment

Device

Laser systems for virtual simulation and patient positioning in radiotherapy

free breathing

Behavioral

Patients breathe calmly while radiotherapy instead of holding their breath.

Primary outcomes

  1. Incidence of subclinical and clinical cardiac events

    Time frame: through study completion, an average of 1 year

    • 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.
    • Subclinical events: new electrocardiogram (ECG) abnormalities, echocardiographic abnormalities, and abnormal elevations of cardiac enzymes after radiotherapy.

Secondary outcomes

  1. Survival

    Time frame: through study completion, an average of 1 year

    Localized regional control rate ,overall survival and disease-related survival.

  2. Cosmetic results

    Time frame: through study completion, an average of 1 year

    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.

  3. Life quality

    Time frame: through study completion, an average of 1 year

    Assessment of patient quality of life by EORTC QLQ-BR23 , a higher score means worse life quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaorong Hou

CONTACT

[email protected]

+86 13811963013

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold for Left Sided Breast Cancer, A Real-World Study

Acronym: DLLEB

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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