Clinical trial NCT02694029: Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer
Official title: Intra-patient Comparison of Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Left-chest Wall Irradiation, a Pilot Study for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Detailed description: Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of ABC-assisted and VisionRT-assisted DIBH. Residual motion during breath-hold will be quantitatively assessed using MV fluoroscopy from the treatment beam itself (i.e., no additional radiation dose). The dosimetric impact of residual motion on organs at risk (heart and lung) will be assessed by applying rigid and/or deformable displacements to the planning CT images, computing the 3D dose map and comparing with the original planned dose map.

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.

Primary outcomes:
measure: Residual Motion During Deep Inspiratory Breath-Hold (DIBH)
timeFrame: All patients received treatment for 2 hours for a minimum of 6 weeks
Secondary outcomes:
measure: Time of Simulation
timeFrame: All patients received treatment for 2 hours for a minimum of 6 weeks
measure: Time of Treatment in Minutes
timeFrame: All patients received treatment for 2 hours for a minimum of 6 weeks
measure: Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion
timeFrame: All patients received treatment for 2 hours for a minimum of 6 weeks
measure: Radiation Dose to Heart
timeFrame: All patients received treatment for 2 hours for a minimum of 6 weeks
measure: Radiation Dose to Lung
timeFrame: All patients received treatment for 2 hours for a minimum of 6 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Asal Rahimi, MD
role: PRINCIPAL_INVESTIGATOR
References: