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

Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Cardiac SPECT perfusion scan

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill, Department of Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women with left-sided breast cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient group; Women with left-sided breast cancer	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-months post radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-months post-treatment

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Timothy M Zagar, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 3, 2013
• First Submitted That Met QC Criteria: May 3, 2013
• First Posted (Estimate): May 8, 2013

Study Record Updates

• Last Update Posted (Estimate): May 12, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Unilateral Breast Neoplasms
• Other Study ID Numbers: LCCC1239