Name (Synonyms) | Correlation | |
---|---|---|
drug1808 | Photobiomodulation Wiki | 1.00 |
drug2113 | Routine Oral Care and Analgesia Wiki | 1.00 |
There is one clinical trial.
The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce the incidence of severe oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving concurrent radiation and chemotherapy.
Description: The primary effectiveness endpoint of the study is the proportion of patients who have severe oral mucositis (Grade 3 or 4) at week 6 of treatment according to the World Health Organization (WHO) Oral Toxicity Scale.
Measure: Incidence of severe oral mucositis (WHO grade 3 and 4) at week 6 of chemoradiation therapy. Time: 6-8 weeks of photobiomodulation and chemoradiation therapyDescription: Radiation therapy oncology group scale (RTOG) 0 (Normal)- 4 (necrosis/hemorrhage), 5= death
Measure: Oral Mucositis (OM) Grade and Incidence, Time: 6-8 weeks, evaluated once per weekDescription: World Health Organization scale (WHO) 0 (Normal)- 4 (oral alimentation not possible), 5= death
Measure: Oral Mucositis (OM) Grade and Incidence, Time: 6-8 weeks, evaluated once per weekDescription: World Health Organization (WHO) analgesic ladder Steps 1-3: 1= non opioid, 2= weak opioid, 3= strong opioid
Measure: Analgesic Usage Time: 6-8 weeks, evaluated daily