A Phase 2 interventional study of N-Acetyl-Cysteine with Institutional standard care and Institutional standard care in Oral Mucositis (Ulcerative) Due to Radiation, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Mansoura University · Phase 2, Interventional, and Prevention
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.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Care
Drug: Institutional standard care
Standard Care plus NAC
Drug: N-Acetyl-Cysteine with Institutional standard care
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)
Benzydamine Mouthwash
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.
Time frame: 8 weeks
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).
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Functional oral intake scale
TUBE DEPENDENT (levels 1-3) 1. No oral intake 2. 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
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
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)
Time frame: 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Mar 2025, 10 months after the start.
Of 39 phase 2 interventional studies under Stomatitis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
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