Carcinoma BreastFB DIBH RTNCT06746142
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
A study testing Deep inspiration breath hold radiotherapy and Free breathing radiotherapy in people with Carcinoma Breast and Radiation Therapy for Primary Breast Cancer, run by Nishat Tasnim at 4 sites in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma Breast, Radiation Therapy for Primary Breast Cancer, Radiation Tolerance
- What is being tested?
- Deep inspiration breath hold radiotherapy and Free breathing radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesBangladesh
- Study dates
- 17 Jul 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Male breast cancer patients.
- Bilateral breast cancer patients.
- Pregnant or lactating women.
- Age ˂ 18 years.
Trial locations and contacts
4 sites in 1 country.
Bangladesh4 sites
Bangabandhu Sheikh Mujib Medical University
Dhaka
Combined Military Hospital, Dhaka
Dhaka
Delta Hospital Limited, Dhaka
Dhaka
Lab Aid Cancer Hospital, Dhaka
Dhaka
About this study
Official 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
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
- Being tested
- Deep inspiration breath hold radiotherapy, Free breathing radiotherapy
- Keywords
- Deep Inspiration Breath Hold Technique, Post mastectomy radiotherapy
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep inspiration breath hold radiotherapyRadiation
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 radiotherapyRadiation
Patient will be advised for free breathing during simulation and treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Deep inspiration breath hold radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose to target volume, left lung and heart
Measured: Immediately after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start17 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nishat Tasnim
- Sponsor type
- University, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Responsible party
- Sponsor-investigator, Nishat Tasnim, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Most. Rokaya Sultana, MBBS, MD, Study director, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746142
- Sponsor's protocol ID
- 5104
- Acronym
- FB DIBH RT
- Status last verified
- Dec 2024
- First submitted
- 17 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06746142
- Acronym / sponsor ID
- FB DIBH RT / 5104
- Conditions
- Carcinoma Breast, Radiation Therapy for Primary Breast Cancer, Radiation Tolerance, Radiation Induced Cardiac Damage, Radiation Induced Lung Injury (RILI), Radiotherapy; Adverse Effect
- Keywords
- Deep Inspiration Breath Hold Technique, Post mastectomy radiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nishat TasnimUniversity, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: FB RT arm | Experimental | Radiation: Free breathing radiotherapyParticipants 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. |
| Arm B: DIBH RT arm | Experimental | Radiation: Deep inspiration breath hold radiotherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep inspiration breath hold radiotherapyParticipants 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. | Radiation | Arm B: DIBH RT arm |
| Free breathing radiotherapyPatient will be advised for free breathing during simulation and treatment. | Radiation | Arm A: FB RT arm |
Primary outcome
Radiation dose to target volume, left lung and heart
Time frame: Immediately after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Most. Rokaya Sultana, MBBS, MD study director
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep inspiration breath hold radiotherapy and Free breathing radiotherapy in people with Carcinoma Breast and Radiation Therapy for Primary Breast Cancer, run by Nishat Tasnim at 4 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose to target volume, left lung and heart (time frame: Immediately after radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.