Oral MucositisNCT07082621
N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients
A study testing N-acetylcysteine (NAC) spray and Conventional treatment in people with Oral Mucositis, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- N-acetylcysteine (NAC) spray and Conventional treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2024to 9 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: Effectiveness of N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (A Randomized Controlled Clinical Trial)
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
- Being tested
- N-acetylcysteine (NAC) spray, Conventional treatment
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteine (NAC) sprayDrug
N-acetylcysteine (NAC) mucoadhesive nanoparticles in the form of spray 3 times daily for 6 weeks
Conventional treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Drug: N-acetylcysteine (NAC) spray |
| Control Group | Active comparator | Not described Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Baseline and 6 weeks
Secondary outcomes (2)
Serum gastrin 17
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
Measured: Baseline and 6 weeks
Change in patient quality of life
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
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 Jan 2024
- Primary completion9 Mar 2025
- Study completion9 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082621
- Sponsor's protocol ID
- 0727072023
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Essam A, Domiaty SE, Attia N, Helal H, Meheissen M. N-acetylcysteine nano-spray versus conventional treatment in the management of radiotherapy-induced oral mucositis in oral cancer patients: a randomized clinical trial. BMC Oral Health. 2026 Mar 20;26(1):616. doi: 10.1186/s12903-026-07959-7.
PubMed 41862922
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of N Acetylcystene in Treatment of Radiotherapy Induced Oral Mucositis in Oral Cancer Patients (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07082621
- Acronym / sponsor ID
- 0727072023
- Conditions
- Oral Mucositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 9 Mar 2025 (actual)
- Study completion
- 9 Mar 2025 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: N-acetylcysteine (NAC) spray |
| Control Group | Active comparator | Drug: Conventional treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine (NAC) sprayN-acetylcysteine (NAC) mucoadhesive nanoparticles in the form of spray 3 times daily for 6 weeks | Drug | Test Group |
| Conventional treatmenttopical 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. | Drug | Control Group |
Primary outcome
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
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).
2 secondary outcomes
Serum gastrin 17
Time frame: Baseline and 6 weeks
Change in patient quality of life
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 41862922Essam A, Domiaty SE, Attia N, Helal H, Meheissen M. N-acetylcysteine nano-spray versus conventional treatment in the management of radiotherapy-induced oral mucositis in oral cancer patients: a randomized clinical trial. BMC Oral Health. 2026 Mar 20;26(1):616. doi: 10.1186/s12903-026-07959-7.
Related trials for Oral Mucositis
Not yet recruiting
Recurrent Aphthous Stomatitis Management in Children Using Diode Laser 980 Nanometer Versus Hyaluronic Acid Gel (RCT)
Apthous Ulcer
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingPhase 3
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma, Stage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-acetylcysteine (NAC) spray and Conventional treatment in people with Oral Mucositis, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain scores (time frame: Baseline,1,2,4,6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07082621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.