NCT02379988

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

Completed NA Results posted Last updated 17 May 2023

What this trial tests

NA trial testing Verify radiation dose to heart and lung in Breast Cancer in 15 participants. Completed in 3 July 2016.

Timeline

6 November 2014

Primary endpoint
3 July 2016

3 July 2016

Quick facts

Lead sponsor	University of Arizona
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	6 November 2014
Primary completion	3 July 2016
Estimated completion	3 July 2016
Sites	1 location across United States

Drugs / interventions tested

• Verify radiation dose to heart and lung

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

University of Arizona

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques. Primary · Treatment Day 1 (both pFB and pDIBH scans were done on the same day)

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 distribu

Free breathing Heart Mean

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	0.9317	± 44.96

Breath Holding Heart mean

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	0.7186	± 11.43

Free breathing Lung mean

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	0.6523	± 52.78

Breath Holding Lung mean

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	0.8746	± 44.81

Free breathing LAD mean

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	2.6159	± 270.58

Breath holding LAD mean

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	2.6231	± 254.61

Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. Secondary · Treatment Day 1

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.

Heart Max free breathing

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	15.7029	± 1424.78

Heart Max breath hold

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	7.1869	± 688.47

Lung max free breathing

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	17.9426	± 1588.08

Lung max breath holding

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	26.6156	± 1392.71

Heart Mean Dose Based on Breast Volume Secondary · Treatment Day 1

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.

Free breathing heart mean in smaller breast volume group

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	109.4	± 54.8

Breath holding heart mean in smaller breast volume group

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	77.5	± 10.4

Free breathing heart mean dose in larger breast volume group

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	71.6	± 8.1

Breath hold heart mean dose in larger breast volume group

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	64.3	± 8.2

Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added. Secondary · Treatment Day 1

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.

Free breathing LAD max

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	9.9154	± 1166.83

Breath holding LAD max

Group	Value	95% CI
Verify Radiation Dose to Heart and Lung	8.3896	± 1108.48

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.