Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients (DERMISHEAD)

Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients

Up to 90% of the radiotherapy patients will develop a certain degree of skin reaction at the treated area, also known as radiodermatitis (RD).

Currently, there is a wide variety of strategies to manage RD, including creams, gels, ointments, wound dressings. However, up to now, there is still no comprehensive, evidence-based consensus for the treatment of RD. Low-level laser therapy (LLLT) is a promising, non-invasive technique for treating RD. In a recent study conducted in our research group, LLLT prevented the aggravation of RD and provided symptomatic relief in patients undergoing radiotherapy for breast cancer after breast-sparing surgery. This was the first prospective study investigating the potential of LLLT for RD. In the current study, we want to investigate the efficacy of LLLT as a tool for the prevention of radiodermatitis in head and neck cancer patients.

Study Overview

• Status: Completed
• Conditions: Head Cancer; Neck Cancer
• Intervention / Treatment: Device: sham laser; Device: Low-level laser therapy

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Hasselt, Belgium, 3500
    • Jessa Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx
• Scheduled for radiotherapy (>60 Gy), chemo-irradiation or bio-radiation either as primary or as post-operative treatment to the head and neck region
• Age ≥ 18 years
• Able to comply to the study protocol
• Able to sign written informed consent
• Signed written informed consent

Exclusion Criteria:

• Previous irradiation to the head and/or neck region
• Metastatic disease
• Patients with pre-existing skin rash, ulceration or open wound in the treatment area
• Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields
• Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
• Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
• Patients using high doses of non-steroidal anti-inflammatory drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control group; Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy	Device: sham laser
EXPERIMENTAL: Treatment Group; Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy	Device: Low-level laser therapy; Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.; Other Names: LLLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Dermatitis Grade	objective scoring of the severity of radiation dermatitis using the grading system of the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC)	3 months (during radiation therapy and one month after)
Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	3 months (during radiation therapy and one month after)
Objective measurement of trans epidermal water loss of the skin	Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin	3 months (during radiation therapy and one month after)
Objective measurement of the skin hydration	Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration	3 months (during radiation therapy and one month after)
Objective measurement of degree of erythema of the skin	Mexameter MX18 will be used to objectively measure the degree of erythema of the skin	3 months (during radiation therapy and one month after)
Analyze the skin cytokine content of the irradiated and non-irradiated breast	Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA	3 months (during radiation therapy and one month after)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS-score	Evaluation of pain using a visual analogue scale (VAS)	3 months (during radiation therapy and one month after)
Skin dex 16	Health-related quality of life measure specific to skin diseases (Skindex-16)	3 months (during radiation therapy and one month after)
Satisfaction with therapy	Self-report on the efficacy of and the global satisfaction with the management of radiodermatitis	3 months (during radiation therapy and one month after)
moist desquamation	Onset time of moist desquamation	3 months (during radiation therapy and one month after)

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (ESTIMATE): April 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Dermatitis; Radiation Injuries; Head and Neck Neoplasms; Radiodermatitis
• Other Study ID Numbers: Dermishead-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED