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

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.

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Key information

Conditions

Carcinoma Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Radiation Induced Cardiac Damage Radiation Induced Lung Injury (RILI) Radiation Injuries Radiation Therapy for Primary Breast Cancer Radiation Tolerance Radiotherapy, Adjuvant Radiotherapy; Adverse Effect Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Deep inspiration breath hold radiotherapy

Radiation

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.

Free breathing radiotherapy

Radiation

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

Primary outcomes

Radiation dose to target volume, left lung and heart

Time frame: Immediately after radiotherapy

Sponsors and collaborators

Lead sponsor

Nishat Tasnim

Other

Collaborators

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Registry information

Official study title

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

Acronym: FB DIBH RT

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Dec 24, 2024
Registry last updated: Dec 24, 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.

Published trials that share one or more normalized conditions with this study.

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