Full Text View
Tabular View
No Study Results Posted
Related Studies
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
This study is ongoing, but not recruiting participants.
Study NCT00573365   Information provided by University of California, Irvine
First Received: December 12, 2007   Last Updated: December 12, 2008   History of Changes

December 12, 2007
December 12, 2008
March 2007
December 2010   (final data collection date for primary outcome measure)
Determine efficacy [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00573365 on ClinicalTrials.gov Archive Site
 
 
 
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study

Radiation dermatitis is a common side-effect of radiation therapy in cancer patients who frequently can experience redness, pain, crusting, and even ulceration of the skin causing suffering and treatment interruption. A recent retrospective study by DeLand demonstrated that administering light emitting diode (LED) photomodulation after each radiation treatment for breast cancer decreased radiation dermatitis in a majority of patients. LED photomodulation is a process by which specific sequences of light are used to regulate or manipulate cell activity without causing heat or damage to the skin. Each LED treatment is painless and is completed in usually less than one minute. LED photomodulation may reduce the suffering associated with radiation treatments, improve cosmetic outcome in radiation fields, and eliminate breaks in radiation treatments which may be required because of severe ulcerating reactions.

This study will attempt to replicate the findings of Dr. DeLand's study by randomly assigning at least 40 breast cancer patients to either a treatment group or to a control group. The treatment group will receive LED photomodulation treatments before and after each radiation treatment with the Gentlewaves Select™ handheld high energy 590nm LED array using specific sequences of pulses used in other studies; the treatment group will also receive 7 additional treatments over 2 weeks after their radiation treatment course is completed. The control group will receive no LED treatment but will use the exact same skin care regimen as the treatment group. In addition to weekly evaluation and grading of skin reactions, subjects will be photographed under standardized conditions weekly and then photographs will be evaluated and graded by blinded dermatologists.

 
 
Interventional
Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Radiation Dermatitis
  • Device: Gentlewaves Select™ handheld high energy LED array
  • Radiation: Radiation
  • Experimental: LED treatment with Gentlewaves Select™ handheld high energy LED array 5 to 10 minutes before each radiation treatment and again 5-10 minutes after each radiation treatment
  • Other: Radiation only
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
40
December 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have clinically diagnosed breast or head and neck cancer that will be treated with radiation therapy.
  • Subjects must be at least 18 years of age

Exclusion Criteria:

  • Subjects will not be eligible to participate if they are pregnant or lactating.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00573365
Douglas Fife, MD, Chao Family Comprehensive Cancer Center
UCI 06-46
University of California, Irvine
 
Principal Investigator: Douglas Fife, MD Chao Family Comprehensive Cancer Center
University of California, Irvine
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP