A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

Study Overview
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Brief Summary
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This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment face-down to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.

Detailed Description
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Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription

Official Title
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A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Radiation Therapy (RT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist Exclusion Criteria: Previous radiation to the ipsilateral breast All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation Therapy (RT)<br>Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription. | Radiation: Radiation Therapy (RT)<br>* Undergo RT either in the supine position with DIBH or in the prone position.<br>* Other names: RT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean cardiac dose | Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose. | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of heart receiving > 20 gray (Gy) | The volume of heart receiving >20Gy in DIBH plan vs. prone plan | Up to 6 weeks | 
| Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan | The mean LAD dose in DIBH plan vs. prone plan | Up to 6 weeks | 
| Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan | The maximum LAD dose in DIBH plan vs. prone plan | Up to 6 weeks | 
| Mean ipsilateral lung dose | The mean ipsilateral lung dose in DIBH plan vs. prone plan | Up to 6 weeks | 
| Volume of ipsilateral lung receiving > 20Gy | The volume of ipsilateral lung receiving >20Gy in DIBH plan vs. prone plan | Up to 6 weeks | 
| Volume of the contralateral breast receiving > 5 Gy | The volume of the contralateral breast receiving >5Gy in DIBH plan vs. prone plan | Up to 6 weeks | 
| Maximum point dose to planning target volume (PTV) breast | The maximum point dose to PTV breast in DIBH plan vs. prone plan | Up to 6 weeks | 
| Maximum separation | The maximum separation in DIBH plan vs. prone plan | Up to 6 weeks | 
| Distance from the mid-sternum to the nipple when the patient is in the prone position | Distance from the mid-sternum to the nipple when the patient is in the prone position | Up to 6 weeks | 
| PTV breast volume as calculated on the prone scan | PTV breast volume as calculated on the prone scan | Up to 6 weeks | 
| Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface) | The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films | Up to 6 weeks | 
| Patient treatment plan (supine with DIBH or prone) | Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan. | Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiation, Prone position, Supine position, DIBH, Invasive Breast Carcinoma, Ductal Breast Carcinoma In Situ