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

Hasselt University

Status

Completed

Conditions

Head Cancer

Neck Cancer

Treatments

Device: sham laser

Device: Low-level laser therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02738268

Dermishead-001

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Volunteers

No Healthy Volunteers

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