Clinical trial NCT02384434: Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma
Official title: Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will assess the efficacy of LLLT to mitigate and ameliorate the acneiform-rash, radiation dermatitis, and pain, while assessing its impact on patient reported quality of life.

Detailed description: This single-arm phase I/II study establishes the safety and efficacy of low level laser therapy (LLLT) in order to mitigate radiation-induced dermatitis in patients underoing radiation therapy for head and neck squamous cell carcinoma (HNSCC). Additional objectives include assessment of patient-reported quality of life data, pain parameters and dermatologic quality of life responses. The target population is patients with histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for either definitive or adjuvant therapy consisting of a chemotherapy regimen and concurrent radiation therapy.

Patients are required to have a favorable performance status (KPS greater than or equal to 70), have had no prior head and neck radiotherapy and be at least 18 years of age and able to provide consent. While receiving radiotherapy and a concurrent systemic regimen, patients will receive LLLT using a 69 diode probe with dual 660 nm and 850 nm wavelengths to at least nine treatment sites in the head and neck region for a duration of 60 seconds to each site. LLLT will be given three times in a week prior to, daily during the first week of, and at least twice weekly thereafter during radiotherapy.

Information collected includes toxicity scoring and quality of life surveys. A retrospective matched-pair design will be used to assess the rate of grade III complications compared to patients treated previously without LLLT support, with an anticipated 20% reduction in the risk of grade III dermatitis.

Eligibility criteria: Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Karnofsky performance status \> 70
* Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* No prior radiotherapy to the head and neck region.
* No previous systemic chemotherapy or targeted therapy
* Must be aware of the neoplastic nature of his/her disease and willingly provide written, informed consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side-effects, risks and discomforts.
* Patients using standard therapies for cetuximab-induced acne-form rash will be included.

Exclusion Criteria:

* Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies
* Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator
* Concurrent serious infection
* Continued use of Niacin

Primary outcomes:
measure: Grade 3 or higher Adverse Events
timeFrame: Up to 12 months
Secondary outcomes:
measure: University of Washington Quality of Life Questionnaire (UW-QOL)
timeFrame: Up to 15 months
measure: Brief Pain Inventory (BPI)
timeFrame: Up to 15 months
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Up to 15 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center - Shadyside Radiation Oncology
state: Pennsylvania
Study officials:
affiliation: UPMC Hillman Cancer Center
name: Heath Skinner, MD
role: PRINCIPAL_INVESTIGATOR
References: