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NCT Number: NCT06354712

Efficacy 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.

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Key information

Conditions

Oral Mucositis (Ulcerative) Due to Radiation Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatitis Stomatognathic Diseases Ulcer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Oncology and Nuclear Medicine of Mansoura University Hospital

Al Mansurah, Egypt

Location status: Recruiting

Location contact

Rasha Abd-Ellatif, Professor

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-Acetyl-Cysteine with Institutional standard care

Drug

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

Institutional standard care

Drug

Benzydamine Mouthwash

Primary outcomes

  1. 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

  1. 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).

  2. 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.

  3. 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.

  4. Functional oral intake scale

    Time frame: 8 weeks

    TUBE DEPENDENT (levels 1-3)

    • No oral intake
    • 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

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Reem Abou-Elezz, BSc

CONTACT

[email protected]

+201065396455

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2024
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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