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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437161
• Other study ID #: 16-01477
• Secondary ID: s16-01477
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2023
• Est. primary completion date: September 26, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Respiratory Aspiration

Intervention

Radiation:
• Radiation Therapy (RT)
Undergo RT either in the supine position with DIBH or in the prone position.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Volume of heart receiving > 20 gray (Gy)	The volume of heart receiving >20Gy in DIBH plan vs. prone plan	Up to 6 weeks
Secondary	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
Secondary	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
Secondary	Mean ipsilateral lung dose	The mean ipsilateral lung dose in DIBH plan vs. prone plan	Up to 6 weeks
Secondary	Volume of ipsilateral lung receiving > 20Gy	The volume of ipsilateral lung receiving >20Gy in DIBH plan vs. prone plan	Up to 6 weeks
Secondary	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
Secondary	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
Secondary	Maximum separation	The maximum separation in DIBH plan vs. prone plan	Up to 6 weeks
Secondary	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
Secondary	PTV breast volume as calculated on the prone scan	PTV breast volume as calculated on the prone scan	Up to 6 weeks
Secondary	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
Secondary	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