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Breast Cancer Lung Late Effects

NCT02725840 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 41

Last updated 2024-08-22

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

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.

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.

PROCEDURE

Computed Tomography (CT) Scan

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

PROCEDURE

Pulmonary Function Test (PFT)

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

Sponsors & Collaborators

  • Florida Department of Health

    collaborator OTHER_GOV

  • University of Florida

    lead OTHER

Principal Investigators

  • Walter O'Dell, PhD · University of Florida

  • Julie Bradley, PhD · University of Florida

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2022-01-14
Completion
2022-01-14

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725840 on ClinicalTrials.gov