Background: Radiotherapy appears to be one of the most effective therapies in head and neck tumors, however, there are a lot of complications related to it. Oral Mucositis is one of the most common complications following radiotherapy. There are currently huge unmet needs for management of oral mucositis. It causes severe pain, reduces food intake and affects quality of life of the head and neck cancer patients .N-acetylcysteine (NAC) is a glutathione precursor which has an antioxidant property and protects against radiation therapy-induced free radical damage. NAC reduces the production of inflammatory markers which leads to decrease inflammation, treats oral mucositis and enhances quality of life of the patient. Aim: To evaluate the effectiveness of N-acetylcysteine and its formulated nanoparticles in treatment of radiotherapy induced oral mucositis in oral cancer patients .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
N-acetylcysteine (NAC) mucoadhesive nanoparticles in the form of spray 3 times daily for 6 weeks
topical anesthetics agents (BBC \[Benzocaine, Benzydamine, and Cetalkonium chloride\] oral spray - oracure gel), topical antifungal agents (Miconaz oral gel)\*, sodium bicarbonate mouth wash (Alkamsir sachets), ice chip,s and anti-inflammatory mouth wash. (Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology \[MASCC/ISSO\] guidelines) 3 times daily for 6 weeks.
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Egypt
Change in pain scores
The Numerical Rating Scale (NRS-11):- where patients are asked to rate their pain on a scale of 0 to 10 where 0 is no pain and 10 is the worst possible pain
Time frame: Baseline,1,2,4,6 weeks
change in oral mucositis severity
Oral mucositis assessment scale (OMAS ) will be used to detect severity of oral mucositis at different mucosal sites in cm2 For each site, erythema is graded from 0 to 2 (none to severe), and ulceration/pseudomembrane formation is graded from 0 to 3 (none to \>3 cm²).
Time frame: Baseline and 6 weeks
Serum gastrin 17
It will be measured at baseline and after 6 weeks by collecting fasting blood samples and analyzed by enzyme immunoassay 201-12-2036 human Gastrin(GAS) ELISA kit (96T) as directed by the manufacturer
Time frame: Baseline and 6 weeks
Change in patient quality of life
Oral health impact profile 14 (OHIP-14):- 14 questions, 0-4 score per question, range 0-14) questionnaires will be used to assess the effect of N -acetyl cysteine application on any change in subjective symptoms and quality of life as experienced by the patient
Time frame: Baseline and 6 weeks
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