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

Completed

• Conditions: Breast Cancer
• Interventions: Other: Cardiac SPECT perfusion scan

• Registration Number: NCT01849614
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient group	Cardiac SPECT perfusion scan	Women with left-sided breast cancer

Primary Outcome Measures

Name	Time	Method
Changes in cardiac perfusion	6-months post radiation	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.

Secondary Outcome Measures

Name	Time	Method
Wall-motion abnormalities	6-months post-treatment	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology; 🇺🇸 Chapel Hill, North Carolina, United States