Oral Mucositis (Ulcerative) Due to RadiationPhase 2NCT06354712
Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
A Phase 2 study of Oral Mucositis (Ulcerative) Due to Radiation, run by Mansoura University at 1 site in Egypt.
Trial summary
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis (Ulcerative) Due to Radiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2024to 1 Mar 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults >18 years diagnosed with squamous cell carcinoma of the head and neck scheduled to receive curative radiotherapy (Primary or postoperative) of at least 50 Gy with or without concurrent chemotherapy.
- Individuals with healthy mucosa.
- Adequate bone marrow function (Hemoglobin level ≥10 g/dL, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter).
- Patients with ECOG performance ≤2
Who cannot join
- History of chemotherapy or radiotherapy.
- Signs of systemic infections.
- Pregnant and lactating women.
- Individuals receiving systemic analgesics.
- Liver disorders and renal failure with eGFR <30 ml/min/1.73m2 (by the MDRD equation).
- Inability to follow instructions and complete the questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Clinical Oncology and Nuclear Medicine of Mansoura University Hospital
Al Mansurah
Rasha Abd-Ellatif, Professor
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients.
- Being tested
- N-Acetyl-Cysteine with Institutional standard care, Institutional standard care
- Keywords
- Oral Mucositis, Radiotherapy, N-acetylcysteine
- Medical subject headings
- Stomatitis, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl-Cysteine with Institutional standard careDrug
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)
Institutional standard careDrug
Benzydamine Mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | Standard Care Receives: Drug: Institutional standard care |
| Interventional arm | Active comparator | Standard Care plus NAC Receives: Drug: N-Acetyl-Cysteine with Institutional standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.
Difference between the two arms regarding incidence of grade ≥ 2 according to World Health Organization scale for Oral Mucositis.
Measured: 8 weeks
Secondary outcomes (5)
Time to develop oral mucositis with grade ≥ 2.
Difference between the two arms regarding time to develop oral mucositis with grade ≥ 2 according to WHO scale for oral mucositis.
World Health Organization scale for oral mucositis
- Grade 0: no oral mucositis
- Grade 1: erythema and soreness
- Grade 2: ulcers, able to eat solids
- Grade 3: ulcers, requires liquid diet
- Grade 4: ulcers, alimentation not possible (due to mucositis).
Measured: 8 weeks
Duration of oral mucositis with grade ≥ 2.
Difference between the two arms regarding duration of oral mucositis with grade ≥ 2 according to WHO scale for oral mucositis.
Measured: 8 weeks
Pain assessed by Visual Analog Scale (VAS).
The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain progression. The most simple VAS is a straight horizontal line of fixed length usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best).
we will allocate this scale in comparing pain severity between the two arms.
Measured: 8 weeks
Functional oral intake scale
TUBE DEPENDENT (levels 1-3)
- No oral intake
- Tube dependent with minimal/inconsistent oral intake 3 Tube supplements with consistent oral intake
TOTAL ORAL INTAKE (levels 4-7) 4. Total oral intake of a single consistency 5. Total oral intake of multiple consistencies requiring special preparation 6. Total oral intake with no special preparation, but must avoid specific foods or liquid items 7. Total oral intake with no restrictions
Measured: 8 weeks
Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4
A questionnaire filled by head and neck cancer patient to assess the quality of life.
H\&N1 I am able to eat the foods that I like H\&N2 My mouth is dry H\&N3 I have trouble breathing H\&N4 My voice has its usual quality and strength H\&N5 I am able to eat as much food as I want H\&N6 I am unhappy with how my face and neck look H\&N7 I can swallow naturally and easily H\&N8 I smoke cigarettes or other tobacco products H\&N9 I drink alcohol (e.g. beer, wine, etc.) H\&N10 I am able to communicate with others H\&N11 I can eat solid foods H\&N12 I have pain in my mouth, throat or neck
Scoring:Not at all (0) A little bit (1) Somewhat (2) Quite a bit (3) Very much(4)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start4 Apr 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Mucositis (Ulcerative) Due to RadiationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
- Investigators
- Mohamed el-Husseiny shams, Professor, Principal investigator, Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura UniversityNoha Mansour, phD, Study director, Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura UniversityRasha Mohamed Abd-Ellatif, Professor, Study director, Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Mansoura UniversityFatma Gharib Khirallah, Associate Professor, Study director, Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Tanta UniversityMohamed Awad Ebrahim, Professor, Study director, Center of Medical Oncology and Adult BMT, Faculty of Medicine, Mansoura University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354712
- Sponsor's protocol ID
- 2024-45
- Status last verified
- Jan 2025
- First submitted
- 3 Apr 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
- ClinicalTrials.gov ID
- NCT06354712
- Acronym / sponsor ID
- 2024-45
- Keywords
- Oral Mucositis, Radiotherapy, N-acetylcysteine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Drug: Institutional standard careStandard Care |
| Interventional arm | Active comparator | Drug: N-Acetyl-Cysteine with Institutional standard careStandard Care plus NAC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults >18 years diagnosed with squamous cell carcinoma of the head and neck scheduled to receive curative radiotherapy (Primary or postoperative) of at least 50 Gy with or without concurrent chemotherapy.
- Individuals with healthy mucosa.
- Adequate bone marrow function (Hemoglobin level ≥10 g/dL, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter).
- Patients with ECOG performance ≤2
Key exclusion criteria (6 listed)
- History of chemotherapy or radiotherapy.
- Signs of systemic infections.
- Pregnant and lactating women.
- Individuals receiving systemic analgesics.
- Liver disorders and renal failure with eGFR <30 ml/min/1.73m2 (by the MDRD equation).
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-Acetyl-Cysteine with Institutional standard careA potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione) | Drug | Interventional arm |
| Institutional standard careBenzydamine Mouthwash | Drug | Control arm |
Primary outcome
Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.
Time frame: 8 weeks
Difference between the two arms regarding incidence of grade ≥ 2 according to World Health Organization scale for Oral Mucositis.
5 secondary outcomes
Time to develop oral mucositis with grade ≥ 2.
Time frame: 8 weeks
Duration of oral mucositis with grade ≥ 2.
Time frame: 8 weeks
Pain assessed by Visual Analog Scale (VAS).
Time frame: 8 weeks
Functional oral intake scale
Time frame: 8 weeks
Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Oral Mucositis (Ulcerative) Due to Radiation
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Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
Active, not recruitingObservational study
Multicentre Real-life Data Collection Study With CareMin650™ in the Prevention and Treatment of Oral Mucositis and Radio- and/or Chemo-induced Dermatitis
Oral Mucositis (Ulcerative), Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy
Not yet recruitingPhase 2
Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis
Oral Mucositis (Ulcerative) Due to Radiation
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.
Mohamed el-Husseiny shams, Professor principal investigator
Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
Noha Mansour, phD study director
Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
Rasha Mohamed Abd-Ellatif, Professor study director
Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Oral Mucositis (Ulcerative) Due to Radiation, run by Mansoura University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reem Abou-Elezz, BSc (+201065396455, reemabouelezz@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2025.