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

January 14, 2025 updated by: Noha Mansour, Mansoura University

Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Mansoura, Egypt
        • Recruiting
        • Clinical Oncology and Nuclear Medicine of Mansoura University Hospital
        • Contact:
          • Rasha Abd-Ellatif, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control arm
Standard Care
Drug: Institutional standard care
Benzydamine Mouthwash
Active Comparator: Interventional arm
Standard Care plus NAC
Drug: N-Acetyl-Cysteine with Institutional standard care
A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Mohamed el-Husseiny shams, Professor, Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University
  • Study Director: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-45

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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