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Dosimetric Comparison of Target Volume, Heart and Left Lung in Post Mastectomy Radiotherapy (RT) of Left Sided Breast Cancer by Free Breathing (FB) Versus Deep Inspiration Breath Hold (DIBH) Technique

Free Breathing Versus Deep Inspiration Breath Hold Technique in Adjuvant Radiotherapy for Left Sided Breast Cancer: A Dosimetric Comparison of Target Volumes, Heart and Left Lung

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06746142
Acronym
FB DIBH RT
Enrollment
50
Registered
2024-12-24
Start date
2024-07-17
Completion date
2025-07-31
Last updated
2024-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma Breast, Radiation Induced Cardiac Damage, Radiation Induced Lung Injury (RILI), Radiation Therapy for Primary Breast Cancer, Radiation Tolerance, Radiotherapy, Adjuvant, Radiotherapy; Adverse Effect

Keywords

Deep Inspiration Breath Hold Technique, Post mastectomy radiotherapy

Brief summary

Breast cancer is a leading cancer among Bangladeshi female. For breast cancer, there are different available treatment options according to the stage of disease. One of the important ones is radiotherapy (RT). Various side effects can occur during and after RT. Among the late side effects, numerous cardiac and pulmonary problems are significant specially in case of left sided breast cancer. In such cases, patients are being cured from cancer but the treatment itself endangering patients' general health and wellbeing by increasing risk of future life threatening cardiac and pulmonary diseases. Studies from around the world have shown that, during RT of left sided breast cancer, holding the breath for certain time after deep inspiration can reduce the radiation doses to heart and left lung without compromising doses to the chest wall. As a result, they can avoid the extra risk of treatment related late toxicities. This study will look at the utility and efficacy of Deep Inspiration Breath Hold (DIBH) RT over free breathing (FB) RT in reducing the heart and left lung doses without compromising the dose to the target volumes in left sided post mastectomy breast cancer patient, which is the main objective of this study.

Interventions

RADIATIONDeep inspiration breath hold radiotherapy

Participants will be trained for 2-3 days for obtaining the desired breathing cycle by trained technologists. No extra equipment will be needed. At first, they will be assured and asked to relax. Then instructed to breath in and out twice followed by a slow, deep breath in to a comfortable higher level than normal and to hold it for at least 20 seconds then again breath normally. Once they are ready with expected breath holding, simulation will be done. Treatment will also be given in this breath holding position.

RADIATIONFree breathing radiotherapy

Patient will be advised for free breathing during simulation and treatment.

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
CollaboratorOTHER
Nishat Tasnim
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Histopathologically proven left sided invasive breast cancer patients who underwent modified radical mastectomy. 2. Post mastectomy patients for whom radiotherapy including supraclavicular irradiation is indicated. 3. Patients having ECOG performance status up to 1.

Exclusion criteria

1. Left sided breast cancer patient underwent BCS. 2. Patient received any chemotherapy other than Doxorubicin, Cyclophosphamide and taxane (Paclitaxel/ Docetaxel) in any settings (neoadjuvant or adjuvant). 3. Patients who have comorbidities that would hinder DIBH (extreme obesity, mental disorder, hypoacusis etc.). 4. Known case of patients with respiratory diseases. 5. Known case of patients with ischemic heart diseases. 6. Patients with previous history of radiotherapy to chest. 7. Male breast cancer patients. 8. Bilateral breast cancer patients. 9. Pregnant or lactating women. 10. Age ˂ 18 years.

Design outcomes

Primary

MeasureTime frame
Radiation dose to target volume, left lung and heartImmediately after radiotherapy

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026