Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer

NCT02694029 | Completed Results DMC

• 1 other identifier: STU 052015-047
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Residual Motion During Deep Inspiratory Breath-Hold (DIBH)

  Residual motion is measured as range of breast/chest wall motion during the ABC or VisionRT assisted DIBH beam delivery. The range of motion will be measured in a unit of millimeter.

  All patients received treatment for 2 hours for a minimum of 6 weeks

Secondary Outcomes (5)

• Time of Simulation

  All patients received treatment for 2 hours for a minimum of 6 weeks

• Time of Treatment in Minutes

  All patients received treatment for 2 hours for a minimum of 6 weeks

• Reproducibility as Measure of Absolute Change of Breathing Chest Wall Excursion

  All patients received treatment for 2 hours for a minimum of 6 weeks

• Radiation Dose to Heart

  All patients received treatment for 2 hours for a minimum of 6 weeks

• Radiation Dose to Lung

  All patients received treatment for 2 hours for a minimum of 6 weeks

Study Arms (2)

ABC (Active Breathing Coordinator ), Then VRT

ACTIVE COMPARATOR

Active Breathing Coordinator to assist radiation therapy. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH

Device: Active Breathing Coordinator (ABC); Device: VisionRT

VisionRT (VRT), Then ABC

ACTIVE COMPARATOR

VisionRT-based deep inspiration breath-hold to assist radiation therapy. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH

Device: Active Breathing Coordinator (ABC); Device: VisionRT

Interventions

Active Breathing Coordinator (ABC) DEVICE

The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH

ABC (Active Breathing Coordinator ), Then VRT; VisionRT (VRT), Then ABC

VisionRT DEVICE

A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH.

Also known as: AlignRT system

ABC (Active Breathing Coordinator ), Then VRT; VisionRT (VRT), Then ABC

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Asal Rahimi, MD
• Organization: UT Southwestern Medical Center

Asal.Rahimi@UTSouthwestern.edu

214/645-8556

Study Officials

• Asal Rahimi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROFESSOR, Radiation Oncology - RO-Radiation Oncology

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 29, 2016
• Study Start: February 1, 2016
• Primary Completion: September 4, 2018
• Study Completion: September 4, 2018
• Last Updated: August 6, 2021
• Results First Posted: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)