Clinical trial NCT02738268: Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients
Official title: Low-level Laser Therapy as a Tool for the Prevention of Radiodermatitis in Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Cancer
Neck Cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2016-04-14
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Radiation Dermatitis Grade
timeFrame: 3 months (during radiation therapy and one month after)
measure: Radiation Dermatitis Assessment
timeFrame: 3 months (during radiation therapy and one month after)
measure: Objective measurement of trans epidermal water loss of the skin
timeFrame: 3 months (during radiation therapy and one month after)
measure: Objective measurement of the skin hydration
timeFrame: 3 months (during radiation therapy and one month after)
measure: Objective measurement of degree of erythema of the skin
timeFrame: 3 months (during radiation therapy and one month after)
measure: Analyze the skin cytokine content of the irradiated and non-irradiated breast
timeFrame: 3 months (during radiation therapy and one month after)
Secondary outcomes:
measure: VAS-score
timeFrame: 3 months (during radiation therapy and one month after)
measure: Skin dex 16
timeFrame: 3 months (during radiation therapy and one month after)
measure: Satisfaction with therapy
timeFrame: 3 months (during radiation therapy and one month after)
measure: moist desquamation
timeFrame: 3 months (during radiation therapy and one month after)
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
References: