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

NCT07082621 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-24

No results posted yet for this study

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

Interventions

DRUG

N-acetylcysteine (NAC) spray

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

DRUG

Conventional 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 & Collaborators

  • Hams Hamed Abdelrahman

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-15
Primary Completion
2025-03-09
Completion
2025-03-09

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082621 on ClinicalTrials.gov