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Completed

NCT Number: NCT03833570

Melatonin for Prevention of Radiation Induced Oral Mucositis

The main aim of this study was to evaluate the effectiveness of melatonin in prevention of radiation induced oral mucositis clinically and biochemically.

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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

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University

Alexandria, Egypt

About this study

The study was designed as randomized, controlled, clinical trial. patients who were undergoing chemoradiation were divided into two groups: Group I: was given conventional treatment. Group II: was given melatonin therapy in combination with the conventional treatment.

All patients were clinically evaluated at the start the radiotherapy, three weeks and six weeks later for pain and oral mucositis severity. in addition, the total antioxidant capacity of the melatonin was evaluated at the start of the radiotherapy and six weeks later.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who are going to receive radiotherapy as a treatment of head and neck cancer either as postoperative (adjuvant) therapy or definitive therapy.
  • Patients whose radiotherapy treatment planned dose is between 60-70 Gy.
  • Patients who had received chemotherapy prior to radiotherapy or are going to receive chemotherapy in concomitant to radiotherapy.

Exclusion criteria

  • Patients under Anticoagulants such as warfarin, heparin, or aspirin.
  • Patients under Fluvoxamine (Luvox) and Nifedipine medications.
  • Patients whose radiotherapy treatment planned dose is lower than 60 Gy.
  • Pregnant and lactating women.
  • Patients suffering from any uncontrolled systemic diseases (such as diabetes, cardiovascular, liver disorder, renal dysfunction)
  • Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.

Treatment and study plan

Rapid Release Capsules Melatonin, 10 mg

Dietary Supplement

Melatonin is a dietary supplement which is naturally produced in the body and closely involved in the natural sleep cycle. recently topical and systemic melatonin supplements. have been proposed as a new therapeutic modality for oral mucositis due to its anti-cancer, anti-inflammatory, and anti-oxidant effects.

Miconaz oral gel

Drug

Antifungal agent

BBC oral spray

Drug

Topical anesthetics and anti-inflammatory agent

Oracure gel

Drug

Topical analgesic gel

Alkamisr sachets

Other

Sodium bicarbonate mouthwash

Primary outcomes

  1. Changes in severity of oral mucositis at different time points along the study

    Time frame: up to 3 and 6 weeks

    Oral mucositis will be evaluated by the World Health Organization (WHO) scale which record the extent and severity of oral mucositis at the third and sixth week after the first radiotherapy session.

    This scale combines both subjective and objective measures of oral mucositis.

    World Health Organization (WHO) 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 (due to mucositis)
    • Grade 4 = Ulcers, alimentation not possible (due to mucositis)

  2. Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study

    Time frame: Baseline (day 0) and up to 6 weeks

    TAC is an index that measures total capacity of antioxidants in biological fluids using Colorimetric Method. it can evaluate the antioxidant response against the free radicals produced by radiotherapy.

    Normal reference values for TAC in saliva: 0.3-1 mM/L Higher values than normal range indicate higher level of TAC

    Changes in the total antioxidant capacity were evaluated at the first day of radiotherapy session (baseline) and six weeks later

Secondary outcomes

  1. Pain and discomfort severity at different time points along the study: Numeric Rating Scale

    Time frame: up to 3 and 6 weeks

    Discomfort and pain severity were reported by each patient using Numeric Rating Scale (NRS) at the third and sixth week after the first radiotherapy session.

    The NRS was calibrated from 0 to 10 with ranges tagged as;

    • No pain (NRS 0)
    • Mild pain (NRS 1-3)
    • Moderate pain (NRS 4-7)
    • Unbearable pain (NRS 8-10)

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Collaborators

  • Alexandria University

Registry information

Official study title

The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2019
Registry last updated
Jun 17, 2019

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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