Trial Outcomes & Findings for Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer (NCT NCT00328783)

Results Overview

To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

At time of radiation

Results posted on

2025-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Active Breathing Coordinator Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Overall Study STARTED	112
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Breathing Coordinator Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Overall Study Could not tolerate ABC	21
Overall Study No heart in RT field	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Breathing Coordinator n=112 Participants Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	54.19 years STANDARD_DEVIATION 10.82 • n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants

PRIMARY outcome

Timeframe: At time of radiation

To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.

Outcome measures

Outcome measures
Measure	Active Breathing Coordinator n=86 Participants Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues Free breathing (heart)	3.0 Gy Interval 2.6 to 3.3
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues ABC (heart)	1.1 Gy Interval 0.9 to 1.3
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues Free breathing (lung)	6.0 Gy Interval 5.3 to 6.8
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues ABC (lung)	5.4 Gy Interval 4.9 to 5.9

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome measures
Measure	Active Breathing Coordinator n=86 Participants Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Proportion of Patients With Reduction in Radiation 5% reduction (heart)	0.94 proportion of patients Interval 0.86 to 0.98
Proportion of Patients With Reduction in Radiation 20% reduction (heart)	0.88 proportion of patients Interval 0.78 to 0.95
Proportion of Patients With Reduction in Radiation 5% reduction (lung)	0.56 proportion of patients Interval 0.41 to 0.7
Proportion of Patients With Reduction in Radiation 20% reduction (lung)	0.35 proportion of patients Interval 0.22 to 0.49

SECONDARY outcome

Timeframe: 30 days post-treatment

Number of participants that experienced grade three toxicity or higher as a result of treatment.

Outcome measures

Outcome measures
Measure	Active Breathing Coordinator n=86 Participants Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Toxicity Evaluation	0 Participants

SECONDARY outcome

Timeframe: 30 days post-treatment

To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.

Outcome measures

Outcome measures
Measure	Active Breathing Coordinator n=86 Participants Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Change in Organs at Risk (OAR) Dosimetric Paramaters Free Breathing (heart)	2.7 Gy Interval 2.3 to 3.1
Change in Organs at Risk (OAR) Dosimetric Paramaters ABC (Heart)	.88 Gy Interval 0.78 to 0.95
Change in Organs at Risk (OAR) Dosimetric Paramaters Free Breathing (Lung)	6.4 Gy Interval 5.7 to 7.0
Change in Organs at Risk (OAR) Dosimetric Paramaters ABC (Lung)	.31 Gy Interval 0.2 to 0.43

SECONDARY outcome

Timeframe: 30 days post-treatment

To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.

Outcome measures

Outcome measures
Measure	Active Breathing Coordinator n=86 Participants Patients breathe through the ABC device Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. Acute skin and soft tissue toxicity : Grade 1	59 Participants
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. Acute skin and soft tissue toxicity : Grade 2	27 Participants
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. Late skin and soft tissue toxicity : Grade 1	34 Participants
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. Late skin and soft tissue toxicity : Grade 2	3 Participants

Adverse Events

Active Breathing Coordinator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rani Anne, MD

Thomas Jefferson University

Phone: 215-955-6045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place