Assessment of Ability of Breath Hold for Left-sided Breast Cancer Radiation Therapy to Reduce Side Effects to Heart

NCT ID: NCT01849614

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-03-31

Brief Summary

The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.

Detailed Description

The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient group

Women with left-sided breast cancer

Cardiac SPECT perfusion scan

Intervention Type: OTHER

A SPECT cardiac perfusion scan provides a three-dimensional map of blood flow to the heart tissue. The scan will be taken at rest only.

Interventions

Cardiac SPECT perfusion scan

A SPECT cardiac perfusion scan provides a three-dimensional map of blood flow to the heart tissue. The scan will be taken at rest only.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• signed an Institutional Review Board (IRB)-approved informed consent document for protocol
• age >= 18 years
• histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
• stage 0-III left-sided breast cancer (including DCIS)
• SPECT score of 0 at baseline
• radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping

Exclusion Criteria

• active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
• symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
• concurrent chemotherapy
• prior receipt of mediastinal radiation therapy
• pregnant or lactating women
• inability to understand and follow breathing instructions for the DIBH procedure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy M Zagar, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

LCCC1239

Identifier Type: -

Identifier Source: org_study_id