Normal Tissue Oxygenation Following Radiotherapy

Completed

• Conditions: Radiation Toxicity

• Registration Number: NCT00677040
• Lead Sponsor: Essentia Health

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-09
• Study First Submitted QC: 2008-05-09
• Study First Posted: 2008-05-13
• Primary Completion: 2009-01
• Study Completion: 2009-08
• Results First Submitted: 2015-09-30
• Results First Submitted QC: 2017-09-22
• Results First Posted: 2018-06-04
• Status Verified: 2024-05
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue Oxygenation	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.

Secondary Outcome Measures

Name	Time	Method
Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured.	One visit

Trial Locations

Locations (1)

Essentia Health; 🇺🇸 Duluth, Minnesota, United States