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

ConditionOral Mucositis (Ulcerative) Due to Radiation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of chemotherapy or radiotherapy.

Signs of systemic infections.

Pregnant and lactating women.

Individuals receiving systemic analgesics.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Control armOther 1 intervention
Group B: Interventional armActive comparator 1 intervention

Trial outcomes

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.

Time frame
8 weeks

Secondary outcomes

1

Time to develop oral mucositis with grade ≥ 2.

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).

Time frame
8 weeks
2

Duration of oral mucositis with grade ≥ 2.

Difference between the two arms regarding duration of oral mucositis with grade ≥ 2 according to WHO scale for oral mucositis.

Time frame
8 weeks
3

Pain assessed by Visual Analog Scale (VAS).

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.

Time frame
8 weeks
4

Functional oral intake scale

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 frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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