Head Cancer, Neck Cancer
Conditions
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.
Interventions
DEVICELow-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.
DEVICEsham laser
Sponsors
Jessa Hospital
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS-score | 3 months (during radiation therapy and one month after) | Evaluation of pain using a visual analogue scale (VAS) |
| 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 |
| moist desquamation | 3 months (during radiation therapy and one month after) | Onset time of moist desquamation |
| Skin dex 16 | 3 months (during radiation therapy and one month after) | Health-related quality of life measure specific to skin diseases (Skindex-16) |
Countries
Belgium
Outcome results
None listed