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

NCT01849614 | Completed DMC

• 1 other identifier: LCCC1239
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Wall-motion abnormalities

  6-months post-treatment

Study Arms (1)

Patient group

Women with left-sided breast cancer

Other: Cardiac SPECT perfusion scan

Interventions

Cardiac SPECT perfusion scan 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.

Patient group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with left-sided breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Timothy M Zagar, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 8, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)