LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

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

Tracking Information

• First Submitted Date: December 12, 2007
• First Posted Date: December 14, 2007
• Last Update Posted Date: August 2, 2017
• Study Start Date: March 2007
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 13, 2007): Determine efficacy [ Time Frame: 6 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Radiation Dermatitis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 21, 2013): 33
• Original Estimated Enrollment (submitted: December 13, 2007): 40
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00573365
• Other Study ID Numbers: 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: 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: University of California, Irvine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Douglas Fife, MD; Chao Family Comprehensive Cancer Center

• PRS Account: University of California, Irvine
• Verification Date: August 2017