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

Neck Cancer Clinical Trial

— DERMISHEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738268
• Other study ID #: Dermishead-001
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2020

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Head Cancer
• Neck Cancer
• Radiodermatitis

Intervention

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.
• sham laser

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Radiation Dermatitis Assessment	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)	3 months (during radiation therapy and one month after)
Primary	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)
Primary	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)
Primary	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)
Primary	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	VAS-score	Evaluation of pain using a visual analogue scale (VAS)	3 months (during radiation therapy and one month after)
Secondary	Skin dex 16	Health-related quality of life measure specific to skin diseases (Skindex-16)	3 months (during radiation therapy and one month after)
Secondary	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)
Secondary	moist desquamation	Onset time of moist desquamation	3 months (during radiation therapy and one month after)