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

Not Applicable

Completed

• Conditions: Head Cancer; Neck Cancer
• Interventions: Device: sham laser; Device: Low-level laser therapy

• Registration Number: NCT02738268
• Lead Sponsor: Hasselt University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-14
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	sham laser	Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Treatment Group	Low-level laser therapy	Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy

Primary Outcome Measures

Name	Time	Method
Radiation Dermatitis Grade	3 months (during radiation therapy and one month after)	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)
Objective measurement of degree of erythema of the skin	3 months (during radiation therapy and one month after)	Mexameter MX18 will be used to objectively measure the degree of erythema of the skin
Radiation Dermatitis Assessment	3 months (during radiation therapy and one month after)	radiation dermatitis assessment scale (Radiation-Induced Skin Reaction Assessment Scale, RISRAS)
Objective measurement of the skin hydration	3 months (during radiation therapy and one month after)	Corneometer CM825 will be used to objectively assess the skin barrier function by measuring the skin hydration
Analyze the skin cytokine content of the irradiated and non-irradiated breast	3 months (during radiation therapy and one month after)	Collect skin tape samples of the irradiated and non-irradiated breast in order to analyze these samples on cytokines by ELISA
Objective measurement of trans epidermal water loss of the skin	3 months (during radiation therapy and one month after)	Tewameter TM 300 will be used to objectively assess the skin barrier function by measuring the trans epidermal water loss of the skin

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium