Clinical trial NCT03437161: A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
Official title: A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Radiation
Prone position
Supine position
DIBH
Invasive Breast Carcinoma
Ductal Breast Carcinoma In Situ
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: Mean cardiac dose
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Volume of heart receiving > 20 gray (Gy)
timeFrame: Up to 6 weeks
measure: Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
timeFrame: Up to 6 weeks
measure: Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
timeFrame: Up to 6 weeks
measure: Mean ipsilateral lung dose
timeFrame: Up to 6 weeks
measure: Volume of ipsilateral lung receiving > 20Gy
timeFrame: Up to 6 weeks
measure: Volume of the contralateral breast receiving > 5 Gy
timeFrame: Up to 6 weeks
measure: Maximum point dose to planning target volume (PTV) breast
timeFrame: Up to 6 weeks
measure: Maximum separation
timeFrame: Up to 6 weeks
measure: Distance from the mid-sternum to the nipple when the patient is in the prone position
timeFrame: Up to 6 weeks
measure: PTV breast volume as calculated on the prone scan
timeFrame: Up to 6 weeks
measure: Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)
timeFrame: Up to 6 weeks
measure: Patient treatment plan (supine with DIBH or prone)
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Laura and Isaac Perlmutter Cancer Center at NYU Langone
name: Naamit Gerber, MD
role: PRINCIPAL_INVESTIGATOR
References: