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

NCT06746142 | Active Not Recruiting FDA Device

• 1 other identifier: 5104
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Deep Inspiration Breath Hold Technique; Post mastectomy radiotherapy

Outcome Measures

Primary Outcomes (1)

• Radiation dose to target volume, left lung and heart

  Immediately after radiotherapy

Study Arms (2)

Arm A: FB RT arm

EXPERIMENTAL

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

Arm B: DIBH RT arm

EXPERIMENTAL

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

Interventions

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.

Arm B: DIBH RT arm

Free breathing radiotherapy RADIATION

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

Arm A: FB RT arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nishat Tasnim: lead
• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: collaborator

Study Sites (4)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Location

Combined Military Hospital, Dhaka

Dhaka, Bangladesh

Location

Delta Hospital Limited, Dhaka

Dhaka, Bangladesh

Location

Lab Aid Cancer Hospital, Dhaka

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Most. Rokaya Sultana, MBBS, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 24, 2024
• Study Start: July 17, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Locations

BA (4)