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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2025-03-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.

NCT06354712

Oral Mucositis (Ulcerative) Due to Radiation

RECRUITING PHASE2

Effect of N-acetyl Cysteine and Zinc in Management of Head and Neck Cancer Radiotherapy Induced Oral Mucositis

NCT06482034

Radiation-Induced Mucositis

COMPLETED PHASE2

Effect of N-Acetyl Cysteine (NAC) on the Oral Microbiome

NCT03982537

Head and Neck Cancer

WITHDRAWN PHASE2

Acetylcysteine Rinse in Reducing Saliva Thickness and Mucositis in Patients With Head and Neck Cancer Undergoing Radiation Therapy

NCT02123511

Mucositis Oral Complications Recurrent Adenoid Cystic Carcinoma of the Oral Cavity +80 more

COMPLETED PHASE2

Efficacy of Glutamine in Management of Radiation Mucositis

NCT05856188

Radiation-Induced Mucositis

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Mucositis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Test Group

Group Type EXPERIMENTAL

N-acetylcysteine (NAC) spray

Intervention Type DRUG

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

Control Group

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N-acetylcysteine (NAC) spray

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No