Melatonin for Prevention of Radiation Induced Oral Mucositis

June 13, 2019 updated by: Hams Hamed Abdelrahman

The Effectiveness of Melatonin in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

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

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

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Melatonin therapy

Rapid Release Capsules Melatonin, 10 mg in combination with the symptomatic treatment

Symptomatic treatment which included:

  • Miconaz oral gel
  • BBC oral spray
  • Oracure gel
  • Alkamisr sachets

Melatonin capsules dose: Two tablets,30 minutes before sleeping once daily for six weeks

Symptomatic treatment dose: Three times a day for six weeks
Drug: BBC oral spray
Topical anesthetics and anti-inflammatory agent
Drug: Oracure gel
Topical analgesic gel
Other: Alkamisr sachets
Sodium bicarbonate mouthwash
Dietary supplement: Rapid Release Capsules Melatonin, 10 mg
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.
Drug: Miconaz oral gel
Antifungal agent
ACTIVE_COMPARATOR: Conventional therapy

Conventional therapy (symptomatic treatment) which included:

  • Miconaz oral gel
  • BBC oral spray
  • Oracure gel
  • Alkamisr sachets

Dose: Three times a day for six weeks
Drug: BBC oral spray
Topical anesthetics and anti-inflammatory agent
Drug: Oracure gel
Topical analgesic gel
Other: Alkamisr sachets
Sodium bicarbonate mouthwash
Drug: Miconaz oral gel
Antifungal agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 3 and 6 weeks
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
Baseline (day 0) and up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 3 and 6 weeks

Collaborators and Investigators

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

Sponsor

Hams Hamed Abdelrahman

Collaborators

Alexandria University

Investigators

  • Principal Investigator: Hossam H Abdelaziz Elsabbagh, BDS, Alexandria University
  • Study Director: Eglal M Moussa, Phd, Alexandria University
  • Study Director: Sabah AH Mahmoud, Phd, University of Alexandria
  • Study Director: Rasha O Elsaka, Phd, University of Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 12, 2018

Primary Completion (ACTUAL)

November 9, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

February 3, 2019

First Submitted That Met QC Criteria

February 6, 2019

First Posted (ACTUAL)

February 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0008839

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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