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NCT06746142Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 24 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
17 Dec 2024
Start date
17 Jul 2024
Primary completion date
Jul 2025
Lead sponsor
Nishat Tasnim
Diseases
Lung cancer
NCT number
NCT06746142

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 17 Jul 2024 to the primary completion date, Jul 2025
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient received any chemotherapy other than Doxorubicin, Cyclophosphamide and taxane (Paclitaxel/ Docetaxel) in any settings (neoadjuvant or adjuvant).
  • Patients with previous history of radiotherapy to chest.

Other illness

  • Left sided breast cancer patient underwent BCS.
  • 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.
  • Male breast cancer patients.
  • Bilateral breast cancer patients.

Age

  • Age ˂ 18 years.

Other

  • Pregnant or lactating women.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bangabandhu Sheikh Mujib Medical University
Coordinator of this site? Confirm its status
DhakaBangladeshUnknown status
Delta Hospital Limited, Dhaka
Coordinator of this site? Confirm its status
DhakaBangladeshUnknown status
Lab Aid Cancer Hospital, Dhaka
Coordinator of this site? Confirm its status
DhakaBangladeshUnknown status
Combined Military Hospital, Dhaka
Coordinator of this site? Confirm its status
DhakaBangladeshUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.