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

NCT ID: NCT02379988

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-06
• Study Completion Date: 2016-07-03

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Verify radiation dose to heart and lung

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victor J Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona Radiation Oncology

Uma Goyal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona Radiation Oncology

Locations

Radiation Oncology Department at the University of Arizona Heath Network

Tucson, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1409500149

Identifier Type: -

Identifier Source: org_study_id