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

UNC Lineberger Comprehensive Cancer Center25 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Interventions

Cardiac SPECT perfusion scanOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Changes in cardiac perfusion

Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation. Any post-radiation summed-rest score (SRS) \> 0 will be counted as a perfusion defect in the calculation of the perfusion defect rate.

Time frame: 6-months post radiation

Secondary Outcomes

Wall-motion abnormalities

The incidence of wall-motion abnormalities will be assessed using SPECT in the same 12 segment scoring system used to quantify perfusion. Wall-motion abnormalities will be recorded as present or absent in each cardiac segment. When present, wall-motion abnormalities wil be classified as gypokinetic, akinetic, or dyskinetic. The extent of wall involvement (small or large portion) will be described as mild or severe.

Time frame: 6-months post-treatment

Data from ClinicalTrials.gov

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