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临床试验/NCT06746142
NCT06746142进行中(未招募)不适用

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

Nishat Tasnim4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
4
主要终点
Radiation dose to target volume, left lung and heart

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Free breathing radiotherapy (Radiation)

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.

干预措施: Deep inspiration breath hold radiotherapy (Radiation)

结局指标

主要结局

Radiation dose to target volume, left lung and heart

时间窗: Immediately after radiotherapy

次要结局

未报告次要终点

研究者

发起方
Nishat Tasnim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nishat Tasnim

Resident

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (4)

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