N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients

NCT07082621 | Completed

• 1 other identifier: 0727072023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  Baseline and 6 weeks

Secondary Outcomes (2)

• Serum gastrin 17

  Baseline and 6 weeks

• Change in patient quality of life

  Baseline and 6 weeks

Study Arms (2)

Test Group

EXPERIMENTAL

Drug: N-acetylcysteine (NAC) spray

Control Group

ACTIVE COMPARATOR

Drug: Conventional treatment

Interventions

N-acetylcysteine (NAC) spray DRUG

N-acetylcysteine (NAC) mucoadhesive nanoparticles in the form of spray 3 times daily for 6 weeks

Test Group

Conventional treatment DRUG

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.

Control Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and biostatistical consultanat

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 24, 2025
• Study Start: January 15, 2024
• Primary Completion: March 9, 2025
• Study Completion: March 9, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

EG (1)