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

NCT06660628 | Recruiting DMC

• 2 other identifiers: K64332022-PUMCH-B-116
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

breast cancer; heart toxicity; DIBH; dose prediction

Outcome Measures

Primary Outcomes (1)

• 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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Survival

  through study completion, an average of 1 year

• Cosmetic results

  through study completion, an average of 1 year

• Life quality

  through study completion, an average of 1 year

Study Arms (2)

Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique

EXPERIMENTAL

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

laser alignment combined with free breathing treatment

ACTIVE COMPARATOR

Patients with left breast cancer treated with traditional laser alignment with free breathing treatment

Radiation: Large Segmentation Radiotherapy; Device: laser alignment; Behavioral: free breathing

Interventions

Large Segmentation Radiotherapy RADIATION

Large Segmentation Radiotherapy±Deep Inspiratory Breath Hold

Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique; laser alignment combined with free breathing treatment

DIBH DEVICE

Deep Inspiration Breath Hold

Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique

Surface guided radiation therapy DEVICE

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

Surface guided radiation therapy (SGRT) combined with Deep Inspiration Breath Hold (DIBH) technique

laser alignment DEVICE

Laser systems for virtual simulation and patient positioning in radiotherapy

laser alignment combined with free breathing treatment

free breathing BEHAVIORAL

Patients breathe calmly while radiotherapy instead of holding their breath.

laser alignment combined with free breathing treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Xiaorong Hou

CONTACT

+86 13811963013; hxr_pumch@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: August 21, 2024
• Primary Completion (Estimated): August 21, 2029
• Study Completion (Estimated): August 21, 2034
• Last Updated: October 28, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)