<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833570</url>
  </required_header>
  <id_info>
    <org_study_id>0008839</org_study_id>
    <nct_id>NCT03833570</nct_id>
  </id_info>
  <brief_title>Melatonin for Prevention of Radiation Induced Oral Mucositis</brief_title>
  <official_title>The Effectiveness of Melatonin in Prevention of Radiation-induced Oral Mucositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hams Hamed Abdelrahman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study was to evaluate the effectiveness of melatonin in prevention of&#xD;
      radiation induced oral mucositis clinically and biochemically.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was designed as randomized, controlled, clinical trial. patients who were&#xD;
      undergoing chemoradiation were divided into two groups: Group I: was given conventional&#xD;
      treatment. Group II: was given melatonin therapy in combination with the conventional&#xD;
      treatment.&#xD;
&#xD;
      All patients were clinically evaluated at the start the radiotherapy, three weeks and six&#xD;
      weeks later for pain and oral mucositis severity. in addition, the total antioxidant capacity&#xD;
      of the melatonin was evaluated at the start of the radiotherapy and six weeks later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 9, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in severity of oral mucositis at different time points along the study</measure>
    <time_frame>up to 3 and 6 weeks</time_frame>
    <description>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.&#xD;
This scale combines both subjective and objective measures of oral mucositis.&#xD;
World Health Organization (WHO) scale for oral mucositis:&#xD;
Grade 0 = No oral mucositis&#xD;
Grade 1 = Erythema and Soreness&#xD;
Grade 2 = Ulcers, able to eat solids&#xD;
Grade 3 = Ulcers, requires liquid diet (due to mucositis)&#xD;
Grade 4 = Ulcers, alimentation not possible (due to mucositis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the total antioxidant capacity (TAC) in saliva at different time points along the study</measure>
    <time_frame>Baseline (day 0) and up to 6 weeks</time_frame>
    <description>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.&#xD;
Normal reference values for TAC in saliva: 0.3-1 mM/L Higher values than normal range indicate higher level of TAC&#xD;
Changes in the total antioxidant capacity were evaluated at the first day of radiotherapy session (baseline) and six weeks later</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain and discomfort severity at different time points along the study: Numeric Rating Scale</measure>
    <time_frame>up to 3 and 6 weeks</time_frame>
    <description>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.&#xD;
The NRS was calibrated from 0 to 10 with ranges tagged as;&#xD;
No pain (NRS 0)&#xD;
Mild pain (NRS 1-3)&#xD;
Moderate pain (NRS 4-7)&#xD;
Unbearable pain (NRS 8-10)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Oral Mucositis (Ulcerative) Due to Radiation</condition>
  <arm_group>
    <arm_group_label>Melatonin therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rapid Release Capsules Melatonin, 10 mg in combination with the symptomatic treatment&#xD;
Symptomatic treatment which included:&#xD;
Miconaz oral gel&#xD;
BBC oral spray&#xD;
Oracure gel&#xD;
Alkamisr sachets&#xD;
Melatonin capsules dose: Two tablets,30 minutes before sleeping once daily for six weeks&#xD;
Symptomatic treatment dose: Three times a day for six weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional therapy (symptomatic treatment) which included:&#xD;
Miconaz oral gel&#xD;
BBC oral spray&#xD;
Oracure gel&#xD;
Alkamisr sachets&#xD;
Dose: Three times a day for six weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Rapid Release Capsules Melatonin, 10 mg</intervention_name>
    <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.</description>
    <arm_group_label>Melatonin therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miconaz oral gel</intervention_name>
    <description>Antifungal agent</description>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_label>Melatonin therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BBC oral spray</intervention_name>
    <description>Topical anesthetics and anti-inflammatory agent</description>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_label>Melatonin therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oracure gel</intervention_name>
    <description>Topical analgesic gel</description>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_label>Melatonin therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alkamisr sachets</intervention_name>
    <description>Sodium bicarbonate mouthwash</description>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_label>Melatonin therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are going to receive radiotherapy as a treatment of head and neck cancer&#xD;
             either as postoperative (adjuvant) therapy or definitive therapy.&#xD;
&#xD;
          -  Patients whose radiotherapy treatment planned dose is between 60-70 Gy.&#xD;
&#xD;
          -  Patients who had received chemotherapy prior to radiotherapy or are going to receive&#xD;
             chemotherapy in concomitant to radiotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under Anticoagulants such as warfarin, heparin, or aspirin.&#xD;
&#xD;
          -  Patients under Fluvoxamine (Luvox) and Nifedipine medications.&#xD;
&#xD;
          -  Patients whose radiotherapy treatment planned dose is lower than 60 Gy.&#xD;
&#xD;
          -  Pregnant and lactating women.&#xD;
&#xD;
          -  Patients suffering from any uncontrolled systemic diseases (such as diabetes,&#xD;
             cardiovascular, liver disorder, renal dysfunction)&#xD;
&#xD;
          -  Patients with findings of any physical or mental abnormality which would interfere&#xD;
             with or be affected by the study procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hossam H Abdelaziz Elsabbagh, BDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eglal M Moussa, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabah AH Mahmoud, Phd</last_name>
    <role>Study Director</role>
    <affiliation>University of Alexandria</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rasha O Elsaka, Phd</last_name>
    <role>Study Director</role>
    <affiliation>University of Alexandria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Outpatient clinic of Department of Clinical Oncology, Faculty of Medicine, Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2010938/</url>
    <description>WHO Handbook for Reporting Results of Cancer Treatment</description>
  </link>
  <reference>
    <citation>Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.</citation>
    <PMID>21133051</PMID>
  </reference>
  <reference>
    <citation>Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.</citation>
    <PMID>15782422</PMID>
  </reference>
  <reference>
    <citation>Campos MI, Campos CN, Aarestrup FM, Aarestrup BJ. Oral mucositis in cancer treatment: Natural history, prevention and treatment. Mol Clin Oncol. 2014 May;2(3):337-340. doi: 10.3892/mco.2014.253. Epub 2014 Feb 7.</citation>
    <PMID>24772297</PMID>
  </reference>
  <reference>
    <citation>Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.</citation>
    <PMID>18360600</PMID>
  </reference>
  <reference>
    <citation>Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.</citation>
    <PMID>28589080</PMID>
  </reference>
  <reference>
    <citation>Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8.</citation>
    <PMID>15605918</PMID>
  </reference>
  <reference>
    <citation>Lee CS, Ryan EJ, Doherty GA. Gastro-intestinal toxicity of chemotherapeutics in colorectal cancer: the role of inflammation. World J Gastroenterol. 2014 Apr 14;20(14):3751-61. doi: 10.3748/wjg.v20.i14.3751.</citation>
    <PMID>24744571</PMID>
  </reference>
  <reference>
    <citation>Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.</citation>
    <PMID>25774860</PMID>
  </reference>
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    <citation>Volpato LE, Silva TC, Oliveira TM, Sakai VT, Machado MA. Radiation therapy and chemotherapy-induced oral mucositis. Braz J Otorhinolaryngol. 2007 Jul-Aug;73(4):562-8. doi: 10.1016/s1808-8694(15)30110-5.</citation>
    <PMID>17923929</PMID>
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    <citation>Moslehi A, Taghizadeh-Ghehi M, Gholami K, Hadjibabaie M, Jahangard-Rafsanjani Z, Sarayani A, Javadi M, Esfandbod M, Ghavamzadeh A. N-acetyl cysteine for prevention of oral mucositis in hematopoietic SCT: a double-blind, randomized, placebo-controlled trial. Bone Marrow Transplant. 2014 Jun;49(6):818-23. doi: 10.1038/bmt.2014.34. Epub 2014 Mar 10.</citation>
    <PMID>24614837</PMID>
  </reference>
  <reference>
    <citation>Hardeland R, Pandi-Perumal SR, Cardinali DP. Melatonin. Int J Biochem Cell Biol. 2006 Mar;38(3):313-6. doi: 10.1016/j.biocel.2005.08.020. Epub 2005 Sep 27.</citation>
    <PMID>16219483</PMID>
  </reference>
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    <citation>Brasure M, MacDonald R, Fuchs E, Olson CM, Carlyle M, Diem S, Koffel E, Khawaja IS, Ouellette J, Butler M, Kane RL, Wilt TJ. Management of Insomnia Disorder [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Dec. Report No.: 15(16)-EHC027-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK343503/</citation>
    <PMID>26844312</PMID>
  </reference>
  <reference>
    <citation>Lyseng-Williamson KA. Melatonin prolonged release: in the treatment of insomnia in patients aged &gt;/=55 years. Drugs Aging. 2012 Nov;29(11):911-23. doi: 10.1007/s40266-012-0018-z.</citation>
    <PMID>23044640</PMID>
  </reference>
  <reference>
    <citation>Lemoine P, Zisapel N. Prolonged-release formulation of melatonin (Circadin) for the treatment of insomnia. Expert Opin Pharmacother. 2012 Apr;13(6):895-905. doi: 10.1517/14656566.2012.667076. Epub 2012 Mar 19.</citation>
    <PMID>22429105</PMID>
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  <reference>
    <citation>Zisapel N. [Controlled release melatonin (Circadin) in the treatment of insomnia in older patients: efficacy and safety in patients with history of use and non-use of hypnotic drugs]. Harefuah. 2009 May;148(5):337-41, 348. Hebrew.</citation>
    <PMID>19630367</PMID>
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    <citation>Zhang HM, Zhang Y. Melatonin: a well-documented antioxidant with conditional pro-oxidant actions. J Pineal Res. 2014 Sep;57(2):131-46. doi: 10.1111/jpi.12162. Epub 2014 Aug 6.</citation>
    <PMID>25060102</PMID>
  </reference>
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    <citation>Najeeb S, Khurshid Z, Zohaib S, Zafar MS. Therapeutic potential of melatonin in oral medicine and periodontology. Kaohsiung J Med Sci. 2016 Aug;32(8):391-6. doi: 10.1016/j.kjms.2016.06.005. Epub 2016 Jul 25.</citation>
    <PMID>27523451</PMID>
  </reference>
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    <citation>Wang YM, Jin BZ, Ai F, Duan CH, Lu YZ, Dong TF, Fu QL. The efficacy and safety of melatonin in concurrent chemotherapy or radiotherapy for solid tumors: a meta-analysis of randomized controlled trials. Cancer Chemother Pharmacol. 2012 May;69(5):1213-20. doi: 10.1007/s00280-012-1828-8. Epub 2012 Jan 24.</citation>
    <PMID>22271210</PMID>
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    <citation>McCormack HM, Horne DJ, Sheather S. Clinical applications of visual analogue scales: a critical review. Psychol Med. 1988 Nov;18(4):1007-19. doi: 10.1017/s0033291700009934.</citation>
    <PMID>3078045</PMID>
  </reference>
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    <citation>Koracevic D, Koracevic G, Djordjevic V, Andrejevic S, Cosic V. Method for the measurement of antioxidant activity in human fluids. J Clin Pathol. 2001 May;54(5):356-61. doi: 10.1136/jcp.54.5.356.</citation>
    <PMID>11328833</PMID>
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    <citation>Rai B, Kaur J, Jacobs R, Singh J. Possible action mechanism for curcumin in pre-cancerous lesions based on serum and salivary markers of oxidative stress. J Oral Sci. 2010 Jun;52(2):251-6. doi: 10.2334/josnusd.52.251.</citation>
    <PMID>20587949</PMID>
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    <citation>Mihandoost E, Shirazi A, Mahdavi SR, Aliasgharzadeh A. Can melatonin help us in radiation oncology treatments? Biomed Res Int. 2014;2014:578137. doi: 10.1155/2014/578137. Epub 2014 May 11.</citation>
    <PMID>24900972</PMID>
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    <citation>Shirzad A, Pouramir M, Seyedmajidi M, Jenabian N, Bijani A, Motallebnejad M. Salivary total antioxidant capacity and lipid peroxidation in patients with erosive oral lichen planus. J Dent Res Dent Clin Dent Prospects. 2014 Winter;8(1):35-9. doi: 10.5681/joddd.2014.006. Epub 2014 Mar 5.</citation>
    <PMID>25024837</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>February 3, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>June 13, 2019</last_update_submitted>
  <last_update_submitted_qc>June 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name>
    <investigator_title>Instructor of Dental Public Health</investigator_title>
  </responsible_party>
  <keyword>Melatonin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Stomatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833570
org study id: 0008839
nct id: NCT03833570
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The main aim of this study was to evaluate the effectiveness of melatonin in prevention of
      radiation induced oral mucositis clinically and biochemically.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Changes in severity of oral mucositis at different time points along the study
time frame: up to 3 and 6 weeks
description: 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)
measure: 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
description: 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
measure: Pain and discomfort severity at different time points along the study: Numeric Rating Scale
time frame: up to 3 and 6 weeks
description: 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)
arm group label: Melatonin therapy
arm group type: Experimental
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
arm group label: Conventional therapy
arm group type: Active Comparator
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: Rapid Release Capsules Melatonin, 10 mg
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.
arm group label: Melatonin therapy
intervention type: Drug
intervention name: Miconaz oral gel
description: Antifungal agent
arm group label: Conventional therapy
arm group label: Melatonin therapy
intervention type: Drug
intervention name: BBC oral spray
description: Topical anesthetics and anti-inflammatory agent
arm group label: Conventional therapy
arm group label: Melatonin therapy
intervention type: Drug
intervention name: Oracure gel
description: Topical analgesic gel
arm group label: Conventional therapy
arm group label: Melatonin therapy
intervention type: Other
intervention name: Alkamisr sachets
description: Sodium bicarbonate mouthwash
arm group label: Conventional therapy
arm group label: Melatonin therapy
criteria: 
gender: All
minimum age: 25 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Hossam H Abdelaziz Elsabbagh, BDS
role: Principal Investigator
affiliation: Alexandria University
last name: Eglal M Moussa, Phd
role: Study Director
affiliation: Alexandria University
last name: Sabah AH Mahmoud, Phd
role: Study Director
affiliation: University of Alexandria
last name: Rasha O Elsaka, Phd
role: Study Director
affiliation: University of Alexandria
facility: 
country: Egypt
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2010938/
description: WHO Handbook for Reporting Results of Cancer Treatment
citation: Feller L, Essop R, Wood NH, Khammissa RA, Chikte UM, Meyerov R, Lemmer J. Chemotherapy- and radiotherapy-induced oral mucositis: pathobiology, epidemiology and management. SADJ. 2010 Sep;65(8):372-4.
PMID: 21133051
citation: Duncan GG, Epstein JB, Tu D, El Sayed S, Bezjak A, Ottaway J, Pater J; National Cancer Institute of Canada Clinical Trials Group. Quality of life, mucositis, and xerostomia from radiotherapy for head and neck cancers: a report from the NCIC CTG HN2 randomized trial of an antimicrobial lozenge to prevent mucositis. Head Neck. 2005 May;27(5):421-8. doi: 10.1002/hed.20162.
PMID: 15782422
citation: Campos MI, Campos CN, Aarestrup FM, Aarestrup BJ. Oral mucositis in cancer treatment: Natural history, prevention and treatment. Mol Clin Oncol. 2014 May;2(3):337-340. doi: 10.3892/mco.2014.253. Epub 2014 Feb 7.
PMID: 24772297
citation: Harris DJ. Cancer treatment-induced mucositis pain: strategies for assessment and management. Ther Clin Risk Manag. 2006 Sep;2(3):251-8. doi: 10.2147/tcrm.2006.2.3.251.
PMID: 18360600
citation: Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089. eCollection 2017.
PMID: 28589080
citation: Sonis ST. Oral mucositis in cancer therapy. J Support Oncol. 2004 Nov-Dec;2(6 Suppl 3):3-8.
PMID: 15605918
citation: Lee CS, Ryan EJ, Doherty GA. Gastro-intestinal toxicity of chemotherapeutics in colorectal cancer: the role of inflammation. World J Gastroenterol. 2014 Apr 14;20(14):3751-61. doi: 10.3748/wjg.v20.i14.3751.
PMID: 24744571
citation: Villa A, Sonis ST. Mucositis: pathobiology and management. Curr Opin Oncol. 2015 May;27(3):159-64. doi: 10.1097/CCO.0000000000000180.
PMID: 25774860
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responsible party type: Sponsor-Investigator
investigator affiliation: Alexandria University
investigator full name: Hams Hamed Abdelrahman
investigator title: Instructor of Dental Public Health
mesh term: Mucositis
mesh term: Stomatitis
mesh term: Melatonin
sharing ipd: No