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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

NCT ID: NCT06746142

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-17

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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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

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Deep Inspiration Breath Hold Technique Post mastectomy radiotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Free breathing radiotherapy

Intervention Type RADIATION

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

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.

Group Type EXPERIMENTAL

Deep inspiration breath hold radiotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Free breathing radiotherapy

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role collaborator

Nishat Tasnim

OTHER

Sponsor Role lead

Responsible Party

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Nishat Tasnim

Resident

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Most. Rokaya Sultana, MBBS, MD

Role: STUDY_DIRECTOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

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Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status

Combined Military Hospital, Dhaka

Dhaka, , Bangladesh

Site Status

Delta Hospital Limited, Dhaka

Dhaka, , Bangladesh

Site Status

Lab Aid Cancer Hospital, Dhaka

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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5104

Identifier Type: -

Identifier Source: org_study_id