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

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ClinicalTrials.gov Identifier: NCT02384434
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
David A. Clump, MD, PhD, University of Pittsburgh

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Radiation Dermatitis Device: Low Level Laser Therapy Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Utilization of Low Level Laser Therapy for Radiation Induced Dermatitis in Patients With Head and Neck Squamous Cell Carcinoma
Study Start Date : April 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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Arm Intervention/treatment
Single Arm
Low Level Laser Therapy
 Device: Low Level Laser Therapy
Red Light Therapy


Outcome Measures
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Primary Outcome Measures :
  1. Measure the safety and tolerability by documentation of Adverse Events [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384434


Contacts
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Contact: Karen Holeva 412-623-1275 holevakd@upmc.edu
Contact: David Clump 412-623-6720 clumpda2@upmc.edu

Locations
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United States, Pennsylvania
UPMC Shadyside Radiation Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Karen D Holeva, BS    412-623-1275    holevakd@upmc.edu   
Contact: David A Clump, MD    412-623-6720    clumpda2@upmc.edu   
Sub-Investigator: Dwight Heron, MD         
Sub-Investigator: Brian Karlovits, DO         
Principal Investigator: David A Clump, MD         
Sub-Investigator: Robert Ferris, MD         
Sub-Investigator: James Ohr, DO         
Sponsors and Collaborators
David A. Clump, MD, PhD
More Information
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Responsible Party: David A. Clump, MD, PhD, Radiation Oncologist, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02384434    
Other Study ID Numbers: RO 14-001
First Posted: March 10, 2015    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Dermatitis
Radiodermatitis
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Skin Diseases
Radiation Injuries
Wounds and Injuries