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Trial Title:
Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
NCT ID:
NCT06354712
Condition:
Oral Mucositis (Ulcerative) Due to Radiation
Conditions: Official terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Acetylcysteine
N-monoacetylcystine
Conditions: Keywords:
Oral Mucositis, Radiotherapy, N-acetylcysteine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
N-Acetyl-Cysteine with Institutional standard care
Description:
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous
antioxidant glutathione)
Arm group label:
Interventional arm
Intervention type:
Drug
Intervention name:
Institutional standard care
Description:
Benzydamine Mouthwash
Arm group label:
Control arm
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
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:
1. History of chemotherapy or radiotherapy.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Clinical Oncology and Nuclear Medicine of Mansoura University Hospital
Address:
City:
Mansoura
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Rasha Abd-Ellatif, Professor
Start date:
April 4, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Mansoura University
Agency class:
Other
Source:
Mansoura University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06354712
