Low Level Laser Therapy for Radiation Induced Dermatitis in H & N Squamous Cell Carcinoma

NCT02384434 | Completed Results DMC FDA Device

• 1 other identifier: HCC 18-128
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

• Grade 3 or Higher Adverse Events

  Number of patients with documented Grade 3 or higher Adverse Events as per CTCAE v4.0.

  Up to 12 months

Secondary Outcomes (21)

• University of Washington Quality of Life Questionnaire (UW-QOL)

  At Baseline

• University of Washington Quality of Life Questionnaire (UW-QOL)

  Up to 4.5 months

• University of Washington Quality of Life Questionnaire (UW-QOL)

  4.5-7.5 months

• University of Washington Quality of Life Questionnaire (UW-QOL)

  7.5-10.5 months

• University of Washington Quality of Life Questionnaire (UW-QOL)

  10.5-13.5 months

Study Arms (1)

Low Level Laser Therapy

OTHER

Non-invasive, cold laser output treatment.

Device: THOR Laser System for Low Level Laser Therapy (LLLT)

Interventions

THOR Laser System for Low Level Laser Therapy (LLLT) DEVICE

Non-invasive, a cold laser output treatment.

Low Level Laser Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heath Skinner: lead

Study Sites (1)

UPMC Hillman Cancer Center - Shadyside Radiation Oncology

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Radiodermatitis

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Results Point of Contact

• Title: Barbara Stadterman, MPH, CCRP
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

4126475554

Study Officials

• Heath Skinner, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 10, 2015
• Study Start: April 27, 2015
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: June 27, 2025
• Results First Posted: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)