This phase I/II trial studies the side effects of low level laser therapy (LLLT) and how well it works in reducing radiation-induced dermatitis (painful, red, itchy, and blistered skin) in patients with head and neck squamous cell carcinoma undergoing radiation therapy. LLLT utilizes the application of light to targeted cells and tissues to facilitate healing. It works by increasing the energy of cells, stimulating repair pathways, and by reducing the harmful molecules known as free radicals which can cause damage to healthy, normal tissues. LLLT may decrease the rate of dermatitis and increase wound healing.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02384434.
Locations matching your search criteria
United States
Pennsylvania
Pittsburgh
UPMC-Shadyside HospitalStatus: Active
Contact: David Anthony Clump
Phone: 412-623-6720
PRIMARY OBJECTIVES:
I. To establish the safety and efficacy of the utilization of low level laser therapy to mitigate radiation-induced dermatitis in patients undergoing definitive or adjuvant radiation therapy with head and neck squamous cell carcinoma.
OUTLINE:
The week prior to standard of care radiation therapy, patients undergo 2 sessions of LLLT over 10-15 minutes each. During the course of standard of care radiation therapy, patients undergo LLLT 3 times weekly for 8 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.
Trial PhasePhase I/II
Trial Typesupportive care
Lead OrganizationUPMC-Shadyside Hospital
Principal InvestigatorDavid Anthony Clump