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 (FB DIBH RT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Radiotherapy, Adjuvant; Carcinoma Breast; Radiation Tolerance; Radiation Induced Cardiac Damage; Radiotherapy; Adverse Effect; Radiation Therapy for Primary Breast Cancer; Radiation Induced Lung Injury (RILI)
• Intervention / Treatment: Radiation: Free breathing radiotherapy; Radiation: Deep inspiration breath hold radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Bangabandhu Sheikh Mujib Medical University
  • Dhaka, Bangladesh
    • Combined Military Hospital, Dhaka
  • Dhaka, Bangladesh
    • Delta Hospital Limited, Dhaka
  • Dhaka, Bangladesh
    • Lab Aid Cancer Hospital, Dhaka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: FB RT arm; Participants will be treated with 40.05 Gy radiation, at 2.67 Gy daily single fraction, 5 days a week, for 3 weeks by IMRT in free breathing technique.	Radiation: Free breathing radiotherapy; Patient will be advised for free breathing during simulation and treatment.
Experimental: Arm B: DIBH RT arm; Participants will be treated with 40.05 Gy radiation, at 2.67 Gy daily single fraction, 5 days a week, for 3 weeks by IMRT in DIBH technique.	Radiation: Deep 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiation dose to target volume, left lung and heart	Immediately after radiotherapy

Collaborators and Investigators

• Sponsor: Nishat Tasnim
• Collaborators: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Investigators: Study Director: Most. Rokaya Sultana, MBBS, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Post mastectomy radiotherapy; Deep Inspiration Breath Hold Technique
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Skin Diseases; Breast Diseases; Thoracic Injuries; Unilateral Breast Neoplasms; Breast Neoplasms; Respiratory Aspiration; Lung Injury
• Other Study ID Numbers: 5104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No