LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

Radiation Dermatitis Clinical Trial

Official title:

LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00573365
• Other study ID #: UCI 06-46
• Secondary ID: 2006-5251
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: August 1, 2017
• Start date: March 2007
• Est. completion date: August 2008

Study information

• Verified date: August 2017
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

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
• Radiation
Weekly radiation treatment

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine efficacy		6 years