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NCT00573365 · ClinicalTrials.gov registry record · NA
LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT00573365 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 33 participants.
The verdict
NCT00573365, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study 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
- RADIATION Radiation
- DEVICE Gentlewaves Select™ handheld high energy LED array
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00573365
The ClinicalTrials.gov registry entry for NCT00573365 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Radiation is the first listed.
NCT00573365 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00573365 about?
NCT00573365 is a clinical study titled "LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis". 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 emitt...
What is the current status of trial NCT00573365?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2007-03. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00573365?
The interventions under investigation include: Radiation (RADIATION), Gentlewaves Select™ handheld high energy LED array (DEVICE).
Who is sponsoring clinical trial NCT00573365?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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