Breast Cancer
Conditions
Keywords
Breast cancer, Active Breathing Control, Active Breathing Coordinator, ABC
Brief summary
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
Detailed description
The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.
Interventions
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.
RADIATIONRadiation Therapy
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields * Adequate pulmonary function * Presence of 5 cc of the heart or liver with the simulation fields * Karnofsky Performance Status (KPS) equal to or greater than 70
Exclusion criteria
* Pregnant women * Patients who have had previous ipsilateral breast or thoracic radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues | 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. |
| Proportion of Patients With Reduction in Radiation | 30 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity Evaluation | 30 days post-treatment | Number of participants that experienced grade three toxicity or higher as a result of treatment. |
| Change in Organs at Risk (OAR) Dosimetric Paramaters | 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. |
| Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. | 30 days post-treatment | To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Could not tolerate ABC | 21 |
| Overall Study | No heart in RT field | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Active Breathing Coordinator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 97 Participants |
| Age, Continuous | 54.19 years STANDARD_DEVIATION 10.82 |
| Region of Enrollment United States | 112 participants |
| Sex: Female, Male Female | 112 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
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.
Time frame: At time of radiation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Breathing Coordinator | Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues | Free breathing (heart) | 3.0 Gy |
| Active Breathing Coordinator | Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues | ABC (heart) | 1.1 Gy |
| Active Breathing Coordinator | Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues | Free breathing (lung) | 6.0 Gy |
| Active Breathing Coordinator | Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues | ABC (lung) | 5.4 Gy |
Primary
Proportion of Patients With Reduction in Radiation
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Breathing Coordinator | Proportion of Patients With Reduction in Radiation | 20% reduction (heart) | 0.88 proportion of patients |
| Active Breathing Coordinator | Proportion of Patients With Reduction in Radiation | 5% reduction (lung) | 0.56 proportion of patients |
| Active Breathing Coordinator | Proportion of Patients With Reduction in Radiation | 20% reduction (lung) | 0.35 proportion of patients |
| Active Breathing Coordinator | Proportion of Patients With Reduction in Radiation | 5% reduction (heart) | 0.94 proportion of patients |
Secondary
Change in Organs at Risk (OAR) Dosimetric Paramaters
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.
Time frame: 30 days post-treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Active Breathing Coordinator | Change in Organs at Risk (OAR) Dosimetric Paramaters | ABC (Heart) | .88 Gy |
| Active Breathing Coordinator | Change in Organs at Risk (OAR) Dosimetric Paramaters | Free Breathing (Lung) | 6.4 Gy |
| Active Breathing Coordinator | Change in Organs at Risk (OAR) Dosimetric Paramaters | ABC (Lung) | .31 Gy |
| Active Breathing Coordinator | Change in Organs at Risk (OAR) Dosimetric Paramaters | Free Breathing (heart) | 2.7 Gy |
Secondary
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.
To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.
Time frame: 30 days post-treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Breathing Coordinator | 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 |
| Active Breathing Coordinator | 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 |
| Active Breathing Coordinator | 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 |
| Active Breathing Coordinator | 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 |
Secondary
Toxicity Evaluation
Number of participants that experienced grade three toxicity or higher as a result of treatment.
Time frame: 30 days post-treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Breathing Coordinator | Toxicity Evaluation | 0 Participants |