Normal Tissue Oxygenation Following Radiotherapy

This study has been completed.
Sponsor:
Information provided by:
Essentia Health
ClinicalTrials.gov Identifier:
NCT00677040
First received: May 9, 2008
Last updated: September 19, 2011
Last verified: September 2011
  Purpose

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
Radiation Oncology

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Normal Tissue Oxygenation Following Radiotherapy

Further study details as provided by Essentia Health:

Primary Outcome Measures:
  • 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. [ Time Frame: One visit for 20 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Archambeau JO, Pezner R, and Wasserman T, Pathophysiology of irradiated skin and breast, Int J Radiat Oncol Biol Phys 1995, 31:1171-1185
. Bui QC, Lieber M, Withers HR, Corson K, van Rijnsoever M, Elsaleh H. The efficacy of hyperbaric oxygen therapy in the treatment of radiation-induced late side effects. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):871-8.
Moore DS and McCabe GP. Introduction to the practice of statistics. New York: W.H. Freeman and Co., 2006.

Responsible Party: Julia-Pattison-Crisostomo, BSN, RN, Essentia Health
ClinicalTrials.gov Identifier: NCT00677040     History of Changes
Other Study ID Numbers: 030804
Study First Received: May 9, 2008
Last Updated: September 19, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014