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

NCT06354712 | Recruiting Phase 2

• 1 other identifier: 2024-45
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis (Ulcerative) Due to Radiation

Keywords

Oral Mucositis, Radiotherapy, N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis.

  Difference between the two arms regarding incidence of grade ≥ 2 according to World Health Organization scale for Oral Mucositis.

  8 weeks

Secondary Outcomes (5)

• Time to develop oral mucositis with grade ≥ 2.

  8 weeks

• Duration of oral mucositis with grade ≥ 2.

  8 weeks

• Pain assessed by Visual Analog Scale (VAS).

  8 weeks

• Functional oral intake scale

  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

Study Arms (2)

Control arm

OTHER

Standard Care

Drug: Institutional standard care

Interventional arm

ACTIVE COMPARATOR

Standard Care plus NAC

Drug: N-Acetyl-Cysteine with Institutional standard care

Interventions

N-Acetyl-Cysteine with Institutional standard care DRUG

A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)

Interventional arm

Institutional standard care DRUG

Benzydamine Mouthwash

Control arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Clinical Oncology and Nuclear Medicine of Mansoura University Hospital

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Stomatitis; Ulcer

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Mohamed el-Husseiny shams, Professor

  Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University

  PRINCIPAL INVESTIGATOR

• Noha Mansour, phD

  Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University

  STUDY DIRECTOR

• Rasha Mohamed Abd-Ellatif, Professor

  Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Mansoura University

  STUDY DIRECTOR

• Fatma Gharib Khirallah, Associate Professor

  Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Tanta University

  STUDY DIRECTOR

• Mohamed Awad Ebrahim, Professor

  Center of Medical Oncology and Adult BMT, Faculty of Medicine, Mansoura University.

  STUDY DIRECTOR

Central Study Contacts

Reem Abou-Elezz, BSc

CONTACT

+201065396455; reemabouelezz@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy and Pharmacy Practice

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: April 4, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

EG (1)