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LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

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: NCT00573365
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE December 12, 2007
First Posted Date  ICMJE December 14, 2007
Last Update Posted Date August 2, 2017
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
Determine efficacy [ Time Frame: 6 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
Official Title  ICMJE LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The enrollment goal of 40 includes 20 for each arm.
Masking: Single (Outcomes Assessor)
Primary Purpose: Device Feasibility
Condition  ICMJE Radiation Dermatitis
Intervention  ICMJE
  • Device: Gentlewaves Select™ handheld high energy LED array
    LED photomodulation within 5-10 minutes before and within 5-10 minutes after each radiation treatment
  • Radiation: Radiation
    Weekly radiation treatment
Study Arms  ICMJE
  • Experimental: Treatment
    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
    Interventions:
    • Device: Gentlewaves Select™ handheld high energy LED array
    • Radiation: Radiation
  • Control
    Radiation only
    Intervention: Radiation: Radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2013)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
40
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Patients treated with partial breast irradiation techniques, brachytherapy, or other non-standard techniques will not be eligible.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00573365
Other Study ID Numbers  ICMJE UCI 06-46
2006-5251 ( Other Identifier: University of California, Irvine )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Chao Family Comprehensive Cancer Center, University of California, Irvine
Original Responsible Party Douglas Fife, MD, Chao Family Comprehensive Cancer Center
Current Study Sponsor  ICMJE University of California, Irvine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Douglas Fife, MD Chao Family Comprehensive Cancer Center
PRS Account University of California, Irvine
Verification Date August 2017

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