Oral Mucositis
Conditions
Brief summary
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 .
Interventions
DRUGN-acetylcysteine (NAC) spray
N-acetylcysteine (NAC) mucoadhesive nanoparticles in the form of spray 3 times daily for 6 weeks
DRUGConventional treatment
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.
Sponsors
Hams Hamed Abdelrahman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with oral cancer by incisional biopsy histological examination. * Patients above the age of 20 years. * Patients receiving radiotherapy either as postoperatory (adjuvant) or as a definitive therapy in the treatment for oral cancer. * Patients with radiotherapy induced-oral mucositis. * Radiation dose ≥ 60 Gy which is responsible for oral mucositis development in oral cancer patients.
Exclusion criteria
* Patients diagnosed with any other type of cancer. * Patients with any systemic disease as diabetes, cardiovascular, liver disorders and kidney disorders. * Patients under anticoagulants such as warfarin, heparin or aspirin. * Patients with findings of any physical or mental abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain scores | Baseline,1,2,4,6 weeks | 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 |
| change in oral mucositis severity | Baseline and 6 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum gastrin 17 | Baseline and 6 weeks | 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 |
| Change in patient quality of life | Baseline and 6 weeks | 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 |
Countries
Egypt
Outcome results
None listed