N/A
N=10
Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02694029 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Residual Motion During Deep Inspiratory Breath-Hold (DIBH) — 0.27; 0.27 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Breathing Coordinator (ABC) (Device); VisionRT (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Motion During Deep Inspiratory Breath-Hold (DIBH) |
0.27; 0.27 | — |
| SECONDARY Time of Simulation |
40.0; 29.8 | — |
| SECONDARY Time of Treatment in Minutes |
9.9; 9.7 | — |
| SECONDARY Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion |
0.51; 0.54 | — |
| SECONDARY Radiation Dose to Heart |
1.6; 1.6 | — |
| SECONDARY Radiation Dose to Lung |
6.3; 6.3 | — |
Summary
Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep Inspiration Breath-Hold (DIBH).
Eligibility Criteria
Inclusion Criteria
- Women with diagnosis of breast malignancy
- Women whom requires left chest wall post-mastectomy radiation with or without bolus
- Age ≥ 18 years.
- Performance status ECOG </=3
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.
- Patient must be able to maintain a 30 second breath hold.
- Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)
Exclusion Criteria
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Data sourced from ClinicalTrials.gov (NCT02694029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.