Laser Therapy for the Prevention of Radiodermatitis in Head and Neck Patients
NCT ID: NCT02738268
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2016-01-31
2020-02-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control group
Control group: receives sham laser (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
sham laser
Treatment Group
Treatment Group: receives low-level laser therapy (2x/week) in combination with standard skin care starting from day 1 of radiotherapy
Low-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.
Interventions
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Low-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.
sham laser
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Jessa Hospital
OTHER
Hasselt University
OTHER
Responsible Party
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Prof. dr. Jeroen Mebis
prof. dr.
Locations
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Ziekenhuis Oost-Limburg
Genk, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Countries
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Other Identifiers
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Dermishead-001
Identifier Type: -
Identifier Source: org_study_id
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