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LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00573365
First received: December 12, 2007
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Radiation Dermatitis
Device: Gentlewaves Select™ handheld high energy LED array
Radiation: Radiation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: LED Photomodulation for Prevention of Post-Radiation Treatment Dermatitis: A Prospective, Randomized, Controlled Study

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Determine efficacy [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Control
Radiation only
Radiation: Radiation
Weekly radiation treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573365

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Douglas Fife, MD Chao Family Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Chao Family Comprehensive Cancer Center, Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00573365     History of Changes
Other Study ID Numbers: UCI 06-46, 2006-5251
Study First Received: December 12, 2007
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
dermatitis
skin
radiation
light
LED photomodulation
Gentlewaves

Additional relevant MeSH terms:
Dermatitis
Radiodermatitis
Radiation Injuries
Skin Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014