ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Ken Dornfeld, 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.


Condition or disease
Radiation Toxicity

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 Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Normal Tissue Oxygenation Following Radiotherapy
Study Start Date : April 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : August 2009



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone breast conserving therapy consisting of lumpectomy and pPatients with breast cancer who received postoperative radiotherapy for breast conservation will be identified from tumor registry data and recruited into the study if they have completed radiotherapy less than one year ostoperative radiotherapy.
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805
Sponsors and Collaborators
Essentia Health
Investigators
Principal Investigator: Kenneth L Dornfeld, MD Essentia Health

Publications:
Moore DS and McCabe GP. Introduction to the practice of statistics. New York: W.H. Freeman and Co., 2006.

Responsible Party: Ken Dornfeld, Radiation Oncologist, Essentia Health
ClinicalTrials.gov Identifier: NCT00677040     History of Changes
Other Study ID Numbers: 030804
First Posted: May 13, 2008    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication