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

NCT ID: NCT06354712

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-04

Study Completion Date

2025-03-01

Brief Summary

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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

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Conditions

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Oral Mucositis (Ulcerative) Due to Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Control arm

Standard Care

Group Type OTHER

Institutional standard care

Intervention Type DRUG

Benzydamine Mouthwash

Interventional arm

Standard Care plus NAC

Group Type ACTIVE_COMPARATOR

N-Acetyl-Cysteine with Institutional standard care

Intervention Type DRUG

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

Interventions

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N-Acetyl-Cysteine with Institutional standard care

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

Intervention Type DRUG

Institutional standard care

Benzydamine Mouthwash

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Noha Mansour

Lecturer of Clinical Pharmacy and Pharmacy Practice

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed el-Husseiny shams, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Noha Mansour, phD

Role: STUDY_DIRECTOR

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

Rasha Mohamed Abd-Ellatif, Professor

Role: STUDY_DIRECTOR

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

Fatma Gharib Khirallah, Associate Professor

Role: STUDY_DIRECTOR

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

Mohamed Awad Ebrahim, Professor

Role: STUDY_DIRECTOR

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

Locations

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Clinical Oncology and Nuclear Medicine of Mansoura University Hospital

Al Mansurah, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Reem Abou-Elezz, BSc

Role: CONTACT

+201065396455

Facility Contacts

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Rasha Abd-Ellatif, Professor

Role: primary

Other Identifiers

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2024-45

Identifier Type: -

Identifier Source: org_study_id

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