Normal Tissue Oxygenation Following Radiotherapy

Essentia Health

Status: Completed

Conditions: Radiation Toxicity

Study type: Observational

Funder types: Other

Identifiers

NCT00677040

030804

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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