Clinical trial NCT06354712: Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
Official title: Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Oral Mucositis (Ulcerative) Due to Radiation
Keywords: Oral Mucositis, Radiotherapy, N-acetylcysteine
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.
timeFrame: 8 weeks
Secondary outcomes:
measure: Time to develop oral mucositis with grade ≥ 2.
timeFrame: 8 weeks
measure: Duration of oral mucositis with grade ≥ 2.
timeFrame: 8 weeks
measure: Pain assessed by Visual Analog Scale (VAS).
timeFrame: 8 weeks
measure: Functional oral intake scale
timeFrame: 8 weeks
measure: Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Clinical Oncology and Nuclear Medicine of Mansoura University Hospital
Study officials:
affiliation: Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
name: Mohamed el-Husseiny shams, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
name: Noha Mansour, phD
role: STUDY_DIRECTOR
affiliation: Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Mansoura University
name: Rasha Mohamed Abd-Ellatif, Professor
role: STUDY_DIRECTOR
affiliation: Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Tanta University
name: Fatma Gharib Khirallah, Associate Professor
role: STUDY_DIRECTOR
affiliation: Center of Medical Oncology and Adult BMT, Faculty of Medicine, Mansoura University.
name: Mohamed Awad Ebrahim, Professor
role: STUDY_DIRECTOR
References: