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Melatonin for Prevention of Radiation Induced Oral Mucositis

Primary Purpose

Oral Mucositis (Ulcerative) Due to Radiation

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Rapid Release Capsules Melatonin, 10 mg

Miconaz oral gel

BBC oral spray

Oracure gel

Alkamisr sachets

About this trial

This is an interventional prevention trial for Oral Mucositis (Ulcerative) Due to Radiation focused on measuring Melatonin

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Melatonin therapy

Conventional therapy

Arm Description

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

Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Dose: Three times a day for six weeks

Outcomes

Primary Outcome Measures

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

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)

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

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 Outcome Measures

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

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)

Full Information

NCT ID

NCT03833570

First Posted

February 3, 2019

Last Updated

June 13, 2019

Sponsor

Hams Hamed Abdelrahman

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT03833570

Brief Title

Melatonin for Prevention of Radiation Induced Oral Mucositis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

January 12, 2018 (Actual)

Primary Completion Date

November 9, 2018 (Actual)

Study Completion Date

December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Hams Hamed Abdelrahman

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Mucositis (Ulcerative) Due to Radiation

Keywords

Melatonin

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Melatonin therapy

Arm Type

Experimental

Arm Description

Arm Title

Conventional therapy

Arm Type

Active Comparator

Arm Description

Conventional therapy (symptomatic treatment) which included: Miconaz oral gel BBC oral spray Oracure gel Alkamisr sachets Dose: Three times a day for six weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Rapid Release Capsules Melatonin, 10 mg

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Miconaz oral gel

Intervention Description

Antifungal agent

Intervention Type

Drug

Intervention Name(s)

BBC oral spray

Intervention Description

Topical anesthetics and anti-inflammatory agent

Intervention Type

Drug

Intervention Name(s)

Oracure gel

Intervention Description

Topical analgesic gel

Intervention Type

Other

Intervention Name(s)

Alkamisr sachets

Intervention Description

Sodium bicarbonate mouthwash

Primary Outcome Measure Information:

Title

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

Description

Time Frame

up to 3 and 6 weeks

Title

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

Description

Time Frame

Baseline (day 0) and up to 6 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

up to 3 and 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hossam H Abdelaziz Elsabbagh, BDS

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eglal M Moussa, Phd

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sabah AH Mahmoud, Phd

Organizational Affiliation

University of Alexandria

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rasha O Elsaka, Phd

Organizational Affiliation

University of Alexandria

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Alexandria

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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Links:

URL

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2010938/

Description

WHO Handbook for Reporting Results of Cancer Treatment

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Melatonin for Prevention of Radiation Induced Oral Mucositis

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