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LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00573365
Enrollment
33
Registered
2007-12-14
Start date
2007-03-31
Completion date
2008-08-31
Last updated
2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Dermatitis

Keywords

dermatitis, skin, radiation, light, LED photomodulation, Gentlewaves

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.

Interventions

DEVICEGentlewaves Select™ handheld high energy LED array

LED photomodulation within 5-10 minutes before and within 5-10 minutes after each radiation treatment

RADIATIONRadiation

Weekly radiation treatment

Sponsors

University of California, Irvine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The enrollment goal of 40 includes 20 for each arm.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Determine efficacy6 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026