Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy

Pilot Study For Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy

This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receive for patients being treated for left sided breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Verify radiation dose to heart and lung

Detailed Description

Subjects have a standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724-5024
      • Radiation Oncology Department at the University of Arizona Heath Network

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients of Dr. Gonzalez
• ≥18 years of age
• Node-negative left breast cancer
• Invasive or DCIS breast cancer
• Prior lumpectomy
• Deemed appropriate for treatment in the prone position by the treating physician
• Able to tolerate prone position and breath hold during CT simulation

Exclusion Criteria:

• <18 years of age
• Patients requiring treatment in supine position

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Verify radiation dose to heart and lung; Subjects will undergo the standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient.

Radiation: Verify radiation dose to heart and lung; This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receives for patients being treated for left sided breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.	The primary endpoints of this study were to evaluate the feasibility of the combination of prone positioning and RPM pDIPH for breast cancer radiation treatment. Each woman enrolled in the study had 2 radiation plans generated: one for the pFB scan and one for the pDIBH scan. The mean difference between the dosimetrically determined heart, left anterior descending (LAD) artery, and left lung radiation doses were computed with the associated 95% confidence interval; however, the Wilcoxin paired signed rank test was used and listed below as the primary analysis because of the non-normal distributions.	Treatment Day 1 (both pFB and pDIBH scans were done on the same day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.	This outcome was measured by looking at the maximum dose to the heart and maximum dose to the left lung in patients using the free breathing method versus the breath holding method in the prone position. The mean of the maximum doses for each patient was taken and compared using the Wilcoxin Paired Signed Rank Test.	Treatment Day 1
Heart Mean Dose Based on Breast Volume	The breast volume was evaluated using the dose-volume histogram. A paired t-test was used to assess if breast volume and the mean difference for heart was statistically significant. Because paired data were generated the number of women required was less than if 2 independent samples of women were to be used.	Treatment Day 1
Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.	This outcome was measured by looking at the maximum dose to the LAD in patients using the free breathing method versus the breath holding method in the prone position. The mean of the maximum doses for each patient was taken and compared using the Wilcoxin Paired Signed Rank Test.	Treatment Day 1

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Victor J Gonzalez, MD, University of Arizona Radiation Oncology; Principal Investigator: Uma Goyal, MD, University of Arizona Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2014
• Primary Completion (Actual): July 3, 2016
• Study Completion (Actual): July 3, 2016

Study Registration Dates

• First Submitted: January 26, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1409500149