Breast Cancer Lung Late Effects

NCT ID: NCT02725840

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2022-01-14

Brief Summary

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.

Detailed Description

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.

Conditions

Radiation Injury; Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Proton beam radiation therapy

The participants in this group will be receiving proton therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).

Proton beam radiation therapy.

Intervention Type: RADIATION

Proton bean radiation therapy interact differently with tissue with the result that protons are absorbed completely within the tissue instead of primarily passing through the entire body. The maximal depth of penetration is dependent upon the incoming velocity (energy) of the protons. Proton therapy utilizes this property to deliver radiation with very little dose beyond the targeted lesion. The dose-rate will be managed as part of the standard of care.

Computed Tomography (CT) Scan

Intervention Type: PROCEDURE

Computed Tomography (CT) Scan of the chest will be performed at 1, 3, 6, 12, 18 and 24 months

Pulmonary Function Test (PFT)

Intervention Type: PROCEDURE

Pulmonary function test (PFT) will be performed at pre-treatment, and at 6 and 12 months.

X-ray based radiation therapy

The participants in this group will be receiving X-ray radiation therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).

X-ray based radiation therapy

Intervention Type: RADIATION

The three-dimensional (3D) mapping of radiation dose distributions permits detailed assessment of local vascular damage as a function of treatment factors of dose, dose-rate. The dose-rate will be managed as part of the standard of care.

Computed Tomography (CT) Scan

Intervention Type: PROCEDURE

Computed Tomography (CT) Scan of the chest will be performed at 1, 3, 6, 12, 18 and 24 months

Pulmonary Function Test (PFT)

Intervention Type: PROCEDURE

Pulmonary function test (PFT) will be performed at pre-treatment, and at 6 and 12 months.

Interventions

Proton beam radiation therapy.

Proton bean radiation therapy interact differently with tissue with the result that protons are absorbed completely within the tissue instead of primarily passing through the entire body. The maximal depth of penetration is dependent upon the incoming velocity (energy) of the protons. Proton therapy utilizes this property to deliver radiation with very little dose beyond the targeted lesion. The dose-rate will be managed as part of the standard of care.

Intervention Type: RADIATION

X-ray based radiation therapy

The three-dimensional (3D) mapping of radiation dose distributions permits detailed assessment of local vascular damage as a function of treatment factors of dose, dose-rate. The dose-rate will be managed as part of the standard of care.

Intervention Type: RADIATION

Computed Tomography (CT) Scan

Computed Tomography (CT) Scan of the chest will be performed at 1, 3, 6, 12, 18 and 24 months

Intervention Type: PROCEDURE

Pulmonary Function Test (PFT)

Pulmonary function test (PFT) will be performed at pre-treatment, and at 6 and 12 months.

Intervention Type: PROCEDURE

Other Intervention Names

PTI; conformal RT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Florida Department of Health

OTHER_GOV

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter O'Dell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Julie Bradley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Department of Radiation Oncology Davis Cancer Pavilion

Gainesville, Florida, United States

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

OCR14962

Identifier Type: OTHER

Identifier Source: secondary_id

6BC09

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB201600387

Identifier Type: -

Identifier Source: org_study_id