Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.

Phase 2

Recruiting

• Conditions: Oral Mucositis (Ulcerative) Due to Radiation
• Interventions: Drug: Institutional standard care; Drug: N-Acetyl-Cysteine with Institutional standard care

• Registration Number: NCT06354712
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-03
• Study Start: 2024-04-04
• Study First Posted: 2024-04-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Institutional standard care	Standard Care
Interventional arm	N-Acetyl-Cysteine with Institutional standard care	Standard Care plus NAC

Primary Outcome Measures

Name	Time	Method
Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.	8 weeks	Difference between the two arms regarding incidence of grade ≥ 2 according to World Health Organization scale for Oral Mucositis.

Secondary Outcome Measures

Name	Time	Method
Duration of oral mucositis with grade ≥ 2.	8 weeks	Difference between the two arms regarding duration of oral mucositis with grade ≥ 2 according to WHO scale for oral mucositis.
Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4	8 weeks	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)
Pain assessed by Visual Analog Scale (VAS).	8 weeks	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.
Functional oral intake scale	8 weeks	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 to develop oral mucositis with grade ≥ 2.	8 weeks	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).

Trial Locations

Locations (1)

Clinical Oncology and Nuclear Medicine of Mansoura University Hospital; 🇪🇬 Mansoura, Egypt