Clinical trial NCT00573365: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Keywords: dermatitis
skin
radiation
light
LED photomodulation
Gentlewaves
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The enrollment goal of 40 includes 20 for each arm.
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Determine efficacy
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Douglas Fife, MD
role: PRINCIPAL_INVESTIGATOR
References: