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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT02738268
• Date of registration: 11/04/2016
• Prospective Registration: No
• Primary sponsor: Hasselt University
• Public title: Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients DERMISHEAD
• Scientific title: Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients
• Date of first enrolment: January 2016
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02738268
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Head Cancer

Neck Cancer

Intervention(s)

Device: Low-level laser therapy

Device: sham laser

Primary Outcome(s)

Objective measurement of the skin hydration [Time Frame: 3 months (during radiation therapy and one month after)]

Radiation Dermatitis Assessment [Time Frame: 3 months (during radiation therapy and one month after)]

Objective measurement of degree of erythema of the skin [Time Frame: 3 months (during radiation therapy and one month after)]

Analyze the skin cytokine content of the irradiated and non-irradiated breast [Time Frame: 3 months (during radiation therapy and one month after)]

Radiation Dermatitis Grade [Time Frame: 3 months (during radiation therapy and one month after)]

Objective measurement of trans epidermal water loss of the skin [Time Frame: 3 months (during radiation therapy and one month after)]

Secondary Outcome(s)

VAS-score [Time Frame: 3 months (during radiation therapy and one month after)]

moist desquamation [Time Frame: 3 months (during radiation therapy and one month after)]

Satisfaction with therapy [Time Frame: 3 months (during radiation therapy and one month after)]

Skin dex 16 [Time Frame: 3 months (during radiation therapy and one month after)]

Secondary ID(s)

Dermishead-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jessa Hospital