Normal Tissue Oxygenation Following Radiotherapy



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:11/2/2018
Start Date:April 2008
End Date:August 2009

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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.

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.

Inclusion Criteria:

1. Diagnosis of breast malignancy

2. Completion of breast irradiation one year (+/- 8 weeks) prior.

3. Surgical treatment with lumpectomy

Exclusion Criteria:

1. Inability to tolerate the 20 minute transcutaneous oxygenation measurements

2. Allergy to adhesives

3. Bilateral disease or absence of control breast or previous radiotherapy to "control"
breast

4. More than one course of radiotherapy to the breast
We found this trial at
1
site
Duluth, Minnesota 55805
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mi
from
Duluth, MN
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