N/A
N=20
Normal Tissue Oxygenation Following Radiotherapy
Radiation Toxicity
Bottom Line
View on ClinicalTrials.gov: NCT00677040 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Tissue Oxygenation — 62.5 mmHg — p=0.5
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Essentia Health
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tissue Oxygenation |
62.5 | 0.5 |
| SECONDARY Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. |
19; 1; 19; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00677040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.