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

NCT02379988 | Completed Results DMC

• 1 other identifier: 1409500149
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  Treatment Day 1

• Heart Mean Dose Based on Breast Volume

  Treatment Day 1

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

  Treatment Day 1

Study Arms (1)

Verify radiation dose to heart and lung

EXPERIMENTAL

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

Interventions

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.

Verify radiation dose to heart and lung

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Radiation Oncology Department at the University of Arizona Heath Network

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Victor Gonzalez
• Organization: Peace Health St. Joseph's cancer center

vgonzalez1@peachehealth.org

360-788-8222

Study Officials

• Victor J Gonzalez, MD

  University of Arizona Radiation Oncology

  PRINCIPAL INVESTIGATOR

• Uma Goyal, MD

  University of Arizona Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: March 5, 2015
• Study Start: November 6, 2014
• Primary Completion: July 3, 2016
• Study Completion: July 3, 2016
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-04

Locations

US (1)