Breast Cancer Lung Late Effects
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/30/2018 |
| Start Date: | May 2016 |
| End Date: | April 2021 |
Early Markers of Subclinical Pulmonary Vascular Radiation Toxicity in Breast Cancer
Through improved early detection and treatment, the number of long term breast cancer
survivors continues to increase. There are now 2.8 million breast cancer survivors in the
U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive
radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence.
Even with advanced radiation techniques for dose conformality to minimize exposure of the
highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical
pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early
diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for
the long term care of these survivors.
The investigators' goal is to better identify breast cancer patients at high risk for
experiencing severe pulmonary toxicity requiring medical intervention, provide a means to
identify toxicity early on, and tailor treatment and/or early intervention on a per-patient
basis.
survivors continues to increase. There are now 2.8 million breast cancer survivors in the
U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive
radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence.
Even with advanced radiation techniques for dose conformality to minimize exposure of the
highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical
pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early
diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for
the long term care of these survivors.
The investigators' goal is to better identify breast cancer patients at high risk for
experiencing severe pulmonary toxicity requiring medical intervention, provide a means to
identify toxicity early on, and tailor treatment and/or early intervention on a per-patient
basis.
This project involves repeat chest computed tomography (CT) imaging and blood draws in
subjects with breast cancer with radiation treatment to the affected breast and chest wall.
The investigators are studying women receiving one of 2 types of radiation, either
conventional X-rays (IMRT) or protons at the University of Florida Health Proton Therapy
Institute (UFHPTI). These subjects typically would not receive follow-up chest CTs as per
standard of care. All subjects will have received a pre-treatment chest CT scan as part of
the treatment planning process. The investigators will enroll 30 subjects in the X-ray
treatment group and 25 subjects in the proton group.
The investigative team has recently solved the technical challenges of extracting and
characterizing lung vascular anatomy from clinical CT images of the chest and used these
tools to characterize acute and chronic changes to pulmonary vascular structure in breast
cancer patients receiving radiation to the chest wall for treatment of their cancer.
In Aim 1 of this study the investigators will compare lung vascular damage in women treated
with conventional radiation with those treated at the UFHPTI. In Aim 2 they will use blood
samples of the subjects of Aim 1 to investigate the differential role of inflammatory
cytokines in the initiation and progression of pulmonary vascular radiation response in
conventional versus proton radiation exposures. Aim 3 compares vascular damage with clinical
pulmonary function assessment using spirometry and diffusion capacity of carbon monoxide
(DLCO). Aim 4 ties together Aims 1-3 by employing and extending existing mathematical models
of radiobiological response to improve and solidify the scientific understanding of the
biological mechanisms of radiation response.
subjects with breast cancer with radiation treatment to the affected breast and chest wall.
The investigators are studying women receiving one of 2 types of radiation, either
conventional X-rays (IMRT) or protons at the University of Florida Health Proton Therapy
Institute (UFHPTI). These subjects typically would not receive follow-up chest CTs as per
standard of care. All subjects will have received a pre-treatment chest CT scan as part of
the treatment planning process. The investigators will enroll 30 subjects in the X-ray
treatment group and 25 subjects in the proton group.
The investigative team has recently solved the technical challenges of extracting and
characterizing lung vascular anatomy from clinical CT images of the chest and used these
tools to characterize acute and chronic changes to pulmonary vascular structure in breast
cancer patients receiving radiation to the chest wall for treatment of their cancer.
In Aim 1 of this study the investigators will compare lung vascular damage in women treated
with conventional radiation with those treated at the UFHPTI. In Aim 2 they will use blood
samples of the subjects of Aim 1 to investigate the differential role of inflammatory
cytokines in the initiation and progression of pulmonary vascular radiation response in
conventional versus proton radiation exposures. Aim 3 compares vascular damage with clinical
pulmonary function assessment using spirometry and diffusion capacity of carbon monoxide
(DLCO). Aim 4 ties together Aims 1-3 by employing and extending existing mathematical models
of radiobiological response to improve and solidify the scientific understanding of the
biological mechanisms of radiation response.
Inclusion Criteria:
- Women who are at least 18 years of age.
- Women with Stage II or higher primary breast cancer and who are scheduled to receive
conventional X-ray RT (n=30) or proton therapy (n=25) to the breast and chest wall.
Exclusion Criteria:
- Patients not willing or able to submit to repeat chest CT scans and blood draws.
- Pregnant women.
- Patients who have previously had radiation treatment where any portion of the lung
received greater than 5 Gy of radiation exposure.
- Women with bilateral breast cancer or metastatic disease to sites near the chest where
additional radiation exposure to any portion of the lung of greater than 5 Gy is
anticipated.
- Women with allergic reaction to all common CT contrast agents.
We found this trial at
2
sites
Jacksonville, Florida 32206
Phone: 904-588-1800
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Gainesville, Florida 32611
Principal Investigator: Walter O'Dell, PhD
Phone: 352-265-0680
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