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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379988
• Other study ID #: 1409500149
• Status: Completed
• Phase: N/A
• Start date: November 6, 2014
• Est. completion date: July 3, 2016

Study information

• Verified date: April 2023
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 3, 2016
• Est. primary completion date: July 3, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Radiation Oncology Department at the University of Arizona Heath Network	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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