Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.
Overview
- Phase
- Phase 2
- Intervention
- Institutional standard care
- Conditions
- Oral Mucositis (Ulcerative) Due to Radiation
- Sponsor
- Mansoura University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Noha Mansour
Lecturer of Clinical Pharmacy and Pharmacy Practice
Mansoura University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Control arm
Standard Care
Intervention: Institutional standard care
Interventional arm
Standard Care plus NAC
Intervention: N-Acetyl-Cysteine with Institutional standard care
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Duration of oral mucositis with grade ≥ 2.(8 weeks)
- Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4(8 weeks)
- Pain assessed by Visual Analog Scale (VAS).(8 weeks)
- Functional oral intake scale(8 weeks)
- Time to develop oral mucositis with grade ≥ 2.(8 weeks)