NCT00677040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
8.8 years until next milestone

Results Posted

Study results publicly available

June 4, 2018

Completed
Last Updated

November 15, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 9, 2008

Results QC Date

September 30, 2015

Last Update Submit

October 29, 2024

Conditions

Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured.

    One visit

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis of breast malignancy
  • Completion of breast irradiation one year (+/- 8 weeks) prior.
  • Surgical treatment with lumpectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essentia Health

Duluth, Minnesota, 55805, United States

Location

Related Publications (14)

  • 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.

    PMID: 12063002BACKGROUND

  • 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.

    PMID: 7713781BACKGROUND

  • 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.

    PMID: 17395042BACKGROUND

  • 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.

    PMID: 17908818BACKGROUND

  • 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.

    PMID: 11013273BACKGROUND

  • 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.

    PMID: 15641107BACKGROUND

  • 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.

    PMID: 16260695BACKGROUND

  • 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.

    PMID: 15465205BACKGROUND

  • 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.

    PMID: 3897335BACKGROUND

  • 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.

    PMID: 7880243BACKGROUND

  • 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.

    PMID: 12393819BACKGROUND

  • 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.

    PMID: 12393820BACKGROUND

  • 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.

    PMID: 6830339BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Ken Dornfeld
Organization
Essentia Health
kenneth.dornfeld@essentiahealth.org
218 786-1311

Study Officials

  • Kenneth L Dornfeld, MD

    Essentia Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

May 9, 2008

First Posted

May 13, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

August 1, 2009

Last Updated

November 15, 2024

Results First Posted

June 4, 2018

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

publication

Locations

US(1)