Clinical trial · Observational
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
NCT01849614CI-TRIAL-00022127completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiac SPECT perfusion scan | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient group
- description
- Women with left-sided breast cancer
- interventionNames
- Other: Cardiac SPECT perfusion scan
Primary outcomes (1)
- measure
- Changes in cardiac perfusion
- timeFrame
- 6-months post radiation
- description
- 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 outcomes (1)
- measure
- Wall-motion abnormalities
- timeFrame
- 6-months post-treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.