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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: Radiation Therapy (RT)

• Registration Number: NCT03437161
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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

Study Timeline

• Study Start: 2017-01-17
• Primary Completion: 2017-09-26
• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-19
• Status Verified: 2023-02
• Study Completion: 2023-02-15
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation Therapy (RT)	Radiation Therapy (RT)	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.

Primary Outcome Measures

Name	Time	Method
Mean cardiac dose	Up to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan	Up to 6 weeks	The maximum LAD dose in DIBH plan vs. prone plan
Volume of ipsilateral lung receiving > 20Gy	Up to 6 weeks	The volume of ipsilateral lung receiving \>20Gy in DIBH plan vs. prone plan
Volume of the contralateral breast receiving > 5 Gy	Up to 6 weeks	The volume of the contralateral breast receiving \>5Gy in DIBH plan vs. prone plan
Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan	Up to 6 weeks	The mean LAD dose in DIBH plan vs. prone plan
Maximum point dose to planning target volume (PTV) breast	Up to 6 weeks	The maximum point dose to PTV breast in DIBH plan vs. prone plan
Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)	Up to 6 weeks	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
Patient treatment plan (supine with DIBH or prone)	Up to 6 weeks	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.
Distance from the mid-sternum to the nipple when the patient is in the prone position	Up to 6 weeks	Distance from the mid-sternum to the nipple when the patient is in the prone position
PTV breast volume as calculated on the prone scan	Up to 6 weeks	PTV breast volume as calculated on the prone scan
Volume of heart receiving > 20 gray (Gy)	Up to 6 weeks	The volume of heart receiving \>20Gy in DIBH plan vs. prone plan
Maximum separation	Up to 6 weeks	The maximum separation in DIBH plan vs. prone plan
Mean ipsilateral lung dose	Up to 6 weeks	The mean ipsilateral lung dose in DIBH plan vs. prone plan