Normal Tissue Oxygenation Following Radiotherapy

Radiation Toxicity Clinical Trial

Official title:

Normal Tissue Oxygenation Following Radiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677040
• Other study ID #: 030804
• Status: Completed
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: May 2024
• Source: Essentia Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiation Toxicity

Locations

Country	Name	City	State
United States	Essentia Health	Duluth	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Essentia Health

Country where clinical trial is conducted

United States, 

References & Publications (14)

Archambeau JO, Pezner R, Wasserman T. Pathophysiology of irradiated skin and breast. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1171-85. doi: 10.1016/0360-3016(94)00423-I. — View Citation

Brizel DM, Wasserman TH, Henke M, Strnad V, Rudat V, Monnier A, Eschwege F, Zhang J, Russell L, Oster W, Sauer R. Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol. 2000 Oct 1;18(19):3339-45. doi: 10.1200/JCO.2000.18.19.3339. Erratum In: J Clin Oncol 2000 Dec 15;18(24):4110-1. — View Citation

Brush J, Lipnick SL, Phillips T, Sitko J, McDonald JT, McBride WH. Molecular mechanisms of late normal tissue injury. Semin Radiat Oncol. 2007 Apr;17(2):121-30. doi: 10.1016/j.semradonc.2006.11.008. — View Citation

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. doi: 10.1016/j.ijrobp.2004.04.019. — View Citation

Delanian S, Depondt J, Lefaix JL. Major healing of refractory mandible osteoradionecrosis after treatment combining pentoxifylline and tocopherol: a phase II trial. Head Neck. 2005 Feb;27(2):114-23. doi: 10.1002/hed.20121. — View Citation

Delanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31. — View Citation

Denham JW, Hauer-Jensen M. The radiotherapeutic injury--a complex 'wound'. Radiother Oncol. 2002 May;63(2):129-45. doi: 10.1016/s0167-8140(02)00060-9. — View Citation

Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. — View Citation

Hauser CJ, Shoemaker WC. Use of a transcutaneous PO2 regional perfusion index to quantify tissue perfusion in peripheral vascular disease. Ann Surg. 1983 Mar;197(3):337-43. doi: 10.1097/00000658-198303000-00014. — View Citation

Marx RE, Johnson RP, Kline SN. Prevention of osteoradionecrosis: a randomized prospective clinical trial of hyperbaric oxygen versus penicillin. J Am Dent Assoc. 1985 Jul;111(1):49-54. doi: 10.14219/jada.archive.1985.0074. — View Citation

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

Rudolph R, Tripuraneni P, Koziol JA, McKean-Matthews M, Frutos A. Normal transcutaneous oxygen pressure in skin after radiation therapy for cancer. Cancer. 1994 Dec 1;74(11):3063-70. doi: 10.1002/1097-0142(19941201)74:113.0.co;2-c. Erratum In: Cancer 1995 Mar 1;75(5):1218. — View Citation

Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989. — View Citation

Westbury CB, Pearson A, Nerurkar A, Reis-Filho JS, Steele D, Peckitt C, Sharp G, Yarnold JR. Hypoxia can be detected in irradiated normal human tissue: a study using the hypoxic marker pimonidazole hydrochloride. Br J Radiol. 2007 Nov;80(959):934-8. doi: 10.1259/bjr/25046649. Epub 2007 Oct 1. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue Oxygenation	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.	One visit for 20 minutes
Secondary	Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured.		One visit