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| Name | Class |
|---|---|
| Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation dose to target volume, left lung and heart | Immediately after radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Most. Rokaya Sultana, MBBS, MD | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangabandhu Sheikh Mujib Medical University | Dhaka | Bangladesh | ||||
| Combined Military Hospital, Dhaka |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2025 | |
| Reset | Dec 11, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 1, 2024 | Dec 17, 2024 |
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| Free breathing radiotherapy | Radiation | Patient will be advised for free breathing during simulation and treatment. |
|
| Dhaka |
| Bangladesh |
| Delta Hospital Limited, Dhaka | Dhaka | Bangladesh |
| Lab Aid Cancer Hospital, Dhaka | Dhaka | Bangladesh |
| Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2025 | Dec 11, 2025 | |||
| Jan 14, 2026 | Feb 2, 2026 | 1 | ||
| Mar 2, 2026 | Mar 20, 2026 | 2 | ||
| Mar 29, 2026 | Apr 17, 2026 | 3 | ||
| Apr 20, 2026 | May 11, 2026 | 4 | ||
| May 13, 2026 | Jun 8, 2026 | 5 | ||
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
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