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Completed

NCT Number: NCT02379988

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radiation Oncology Department at the University of Arizona Heath Network

Tucson, Arizona, 85724-5024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verify radiation dose to heart and lung

Radiation

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.

Primary outcomes

  1. The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.

    Time frame: 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 distributions.

Secondary outcomes

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

    Time frame: 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.

  2. Heart Mean Dose Based on Breast Volume

    Time frame: 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.

  3. Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2015
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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