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Trial Title:
Large Segmentation Radiotherapy ± Deep Inspiration Breath Hold(DIBH) for Left Breast Cancer
NCT ID:
NCT06660628
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast cancer
heart toxicity
DIBH
dose prediction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Large Segmentation Radiotherapy
Description:
Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold
Arm group label:
Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique
Arm group label:
laser alignment combined with free breathing treatment
Intervention type:
Device
Intervention name:
DIBH
Description:
Deep Inspiration Breath Hold
Arm group label:
Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique
Intervention type:
Device
Intervention name:
Surface guided radiation therapy
Description:
The technology uses modern 3D camera technology to help track and monitor patient
movements during set-up and treatment.
Arm group label:
Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique
Intervention type:
Device
Intervention name:
laser alignment
Description:
Laser systems for virtual simulation and patient positioning in radiotherapy
Arm group label:
laser alignment combined with free breathing treatment
Intervention type:
Behavioral
Intervention name:
free breathing
Description:
Patients breathe calmly while radiotherapy instead of holding their breath.
Arm group label:
laser alignment combined with free breathing treatment
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaorong Hou
Phone:
+86 13811963013
Email:
hxr_pumch@163.com
Start date:
August 21, 2024
Completion date:
August 21, 2034
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06660628
