Normal Tissue Oxygenation Following Radiotherapy
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Normal Tissue Oxygenation Following Radiotherapy|
- 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. [ Time Frame: One visit for 20 minutes ] [ Designated as safety issue: No ]
- Skin and soft tissue toxicity will be assessed using the RTOG/EORTC Late Radiation Morbidity Scoring Schema when oxygenation is measured. [ Time Frame: One visit ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00677040
|United States, Minnesota|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Kenneth L Dornfeld, MD||Essentia Health|