Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With… (NCT05176834) | Clinical Trial Compass
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Photobiomodulation Home-use Device for Prevention or Treatment of Oral Mucositis in Patients With Head&Neck Malignancies
Israel20 participantsStarted 2022-01-31
Plain-language summary
Patients with head and neck malignancy that are treated with Radiation Therapy \[RT\] are expected to develop Oral Mucositis (OM) in 60% of cases. Mucositis is a side effect of radiation and / or chemotherapy that causes severe pain and inability to eat and drink and a decrease in quality of life. In addition it may impair the treatment protocol and treatment outcomes.
Photobiomodulation is a non-ionizing optical radiation in the near or near-infrared range used for acceleration of wound healing and pain reduction. Photobiomodulation therapy for the reduction of mucositis is included in the International Guidelines of the MASCC / ISOO Association and the British NICE. To date the treatment has been performed by members of professional medical staff in hospitals or clinics.
The study device is home-used photobiomodulation device approved for indications of pain reduction and acceleration of wound healing. The device has shown efficacy in treating mucositis around dental implants in a clinical trial and after oncological treatments in a limited number of cases as reported in the scientific literature.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients with malignant neoplasm in the oral cavity, pharynx or salivary glands.
✓. The patient should receive a continuous course of radiation therapy (IMRT) with all of the following criteria applicable:
✓. A patient with an ECOG PS functional status equal to or less than 2
✓. Able to read and understand the informed consent form (ICF) and voluntarily provided informed consent
✓. The patient is able to undergo intra-oral treatments
✓. The patient is willing to perform the protocol.
Exclusion criteria
✕. The patient underwent previous radiation to the current therapeutic field
✕. The patient has health conditions of the teeth or mouth that will prevent the application of intra-oral treatment
✕. The patient receives non-standard treatment for mucositis such as benzidamine, palifermin, etc.
What they're measuring
1
Proportion of patients performing at least 50% of expected daily treatments during radiotherapy period.