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OpenTrials
Completed

NCT Number: NCT00677040

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.

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Key information

Conditions

Radiation Toxicity Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Essentia Health

Duluth, Minnesota, 55805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Essentia Health

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 13, 2008
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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