Normal Tissue Oxygenation Following Radiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00677040|
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Normal Tissue Oxygenation Following Radiotherapy|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||August 2009|
- 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.
- 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 ]RTOG late skin toxicity score was 1 (no toxicity) for 19 subjects and 2 (discernible difference between treated and nontreated breast) in one subject RTOG late subcutaneous tissue toxicity score was 1 (no toxicity) for 19 subjects and 2 (discernible difference between treated and nontreated breast) in one subject
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00677040
|United States, Minnesota|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Kenneth L Dornfeld, MD||Essentia Health|