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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Radiation Therapy (RT)

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: Radiation Therapy (RT); Undergo RT either in the supine position with DIBH or in the prone position.; Other Names: Cancer Radiotherapy; Radiotherapy; RT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Naamit Gerber, MD, Laura and Isaac Perlmutter Cancer Center at NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): September 26, 2017
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Prone position; Radiation; Supine position; DIBH; Invasive Breast Carcinoma; Ductal Breast Carcinoma In Situ
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: 16-01477; s16-01477 (Other Identifier: New York University School of Medicine)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No