Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
NCT ID: NCT06354712
Last Updated: 2025-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2024-04-04
2025-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control arm
Standard Care
Institutional standard care
Benzydamine Mouthwash
Interventional arm
Standard Care plus NAC
N-Acetyl-Cysteine with Institutional standard care
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)
Interventions
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N-Acetyl-Cysteine with Institutional standard care
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)
Institutional standard care
Benzydamine Mouthwash
Eligibility Criteria
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Inclusion Criteria
2. Individuals with healthy mucosa.
3. Adequate bone marrow function (Hemoglobin level ≥10 g/dL, platelet count ≥75 × 103/microliter, and absolute neutrophil count ≥1.5 × 103/microliter).
4. Patients with ECOG performance ≤2
Exclusion Criteria
2. Signs of systemic infections.
3. Pregnant and lactating women.
4. Individuals receiving systemic analgesics.
5. Liver disorders and renal failure with eGFR \<30 ml/min/1.73m2 (by the MDRD equation).
6. Inability to follow instructions and complete the questionnaires.
18 Years
80 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Noha Mansour
Lecturer of Clinical Pharmacy and Pharmacy Practice
Principal Investigators
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Mohamed el-Husseiny shams, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
Noha Mansour, phD
Role: STUDY_DIRECTOR
Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
Rasha Mohamed Abd-Ellatif, Professor
Role: STUDY_DIRECTOR
Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Mansoura University
Fatma Gharib Khirallah, Associate Professor
Role: STUDY_DIRECTOR
Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Tanta University
Mohamed Awad Ebrahim, Professor
Role: STUDY_DIRECTOR
Center of Medical Oncology and Adult BMT, Faculty of Medicine, Mansoura University.
Locations
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Clinical Oncology and Nuclear Medicine of Mansoura University Hospital
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Rasha Abd-Ellatif, Professor
Role: primary
Other Identifiers
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2024-45
Identifier Type: -
Identifier Source: org_study_id
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