Normal Tissue Oxygenation Following Radiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Radiation Toxicity
- Sponsor
- Essentia Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Tissue Oxygenation
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study involves women who have had a diagnosis of breast cancer, and have had a lumpectomy with radiation treatments completed in the past year.
The study will determine the level of oxygen in the skin of the breast that has been radiated, compared with the normal skin of the opposite breast.
The purpose of this study is to determine if there is a decrease in oxygen levels in the skin which has been radiated, hopefully to find a treatment to limit skin damage caused by radiation treatments, for women with breast cancer in the future.
Detailed Description
Successful completion of this study will provide data on changes in oxygenation in irradiated tissues. If changes are documented, this study would provide evidence supporting current models of tissue injury following radiotherapy. In addition, these data may provide a mechanistic rationale for clinical approaches to ameliorate the toxicities of radiotherapy. Finally, if a correlation exists between tissue oxygenation and toxicity, the rapid and simple tissue oxygenation test may provide a quantitative measure of toxicity and allow earlier and more precise assessment of both toxicity and efficacy of ameliorative therapies.
Investigators
Ken Dornfeld
Radiation Oncologist
Essentia Health
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of breast malignancy
- •Completion of breast irradiation one year (+/- 8 weeks) prior.
- •Surgical treatment with lumpectomy
Exclusion Criteria
- •Inability to tolerate the 20 minute transcutaneous oxygenation measurements
- •Allergy to adhesives
- •Bilateral disease or absence of control breast or previous radiotherapy to "control" breast
- •More than one course of radiotherapy to the breast
Outcomes
Primary Outcomes
Tissue Oxygenation
Time Frame: One visit for 20 minutes
Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area.
Secondary Outcomes
- Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured.(One visit)