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NCT Number: NCT07082621

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

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 .

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Key information

Conditions

Oral Mucositis Mouth Diseases Stomatitis Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine (NAC) spray

Drug

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

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.

Primary outcomes

  1. Change in pain scores

    Time frame: 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

  2. change in oral mucositis severity

    Time frame: 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 outcomes

  1. Serum gastrin 17

    Time frame: 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

  2. Change in patient quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Effectiveness of N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (A Randomized Controlled Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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