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Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients

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ClinicalTrials.gov Identifier: NCT02430298
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
Ubon Ratchathani Cancer Hospital, Ubon Ratchathani
General Drugs House Co.,LTD.
Information provided by (Responsible Party):
Nutjaree Pratheepawanit Johns, Khon Kaen University

Brief Summary:
The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and adverse event frequency.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: Melatonin Drug: Matched Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients
Study Start Date : July 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Matched placebo
Drug: match placebo Drug: placebo suspension gargle for 2 minutes before radiation 15 minutes and placebo gelatin capsule taken orally after 21:00 hours each night throughout the study
Drug: Matched Placebo
Drug: Melatonin 20 mg/ 10 ml placebo suspension gargle for 2 minutes before radiation 15 minutes and 20 mg placebo gelatin capsule taken orally after 21:00 hours each night throughout the study
Other Names:
  • 20 mg/10 ml placebo suspensions
  • 20 mg placebo gelatin capsule

Active Comparator: Melatonin
Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study
Drug: Melatonin
Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study
Other Names:
  • 20 mg/10 ml melatonin suspensions
  • 20 mg melatonin gelatin capsule




Primary Outcome Measures :
  1. Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores [ Time Frame: Time to event (occurence of mucositis level 3) during 7 weeks of treatment ]
    Participants will be followed for severity of mucositis during the treatment period of 7 weeks


Secondary Outcome Measures :
  1. Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale [ Time Frame: Time to event (occurence of mucositis level 3) during 7 weeks of treatment ]
    Participants will be followed for severity of xerostomia during the treatment period of 7 weeks

  2. Quality of Life (FACT- H&N Version 4) [ Time Frame: Change from baseline in Trial Outcome Index scores at 7th week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New diagnostic of head and neck cancer patient who need treatment with radiation involved with the oral cavity area.
  • Never received radiotherapy or chemotherapy
  • Karnofsky performance status > 70%
  • Stopped smoking
  • Able to eat and swallow medications
  • Written informed consent

Exclusion Criteria:

  • Melatonin allergy
  • Active oral cavity inflammation scar
  • Pregnancy
  • Creatinine clearance < 30 ml/min
  • Active periodontal disease
  • Steroids or pain killer drugs used for oral cavity pain except NSAIDs for thromboembolism prevention
  • Currently use benzydamine mouthwash

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430298


Locations
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Thailand
Ubon Ratchathani Cancer Hospital
Ubon Ratchathani, Thailand, 34000
Sponsors and Collaborators
Khon Kaen University
Ubon Ratchathani Cancer Hospital, Ubon Ratchathani
General Drugs House Co.,LTD.

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Responsible Party: Nutjaree Pratheepawanit Johns, Khon Kaen University
ClinicalTrials.gov Identifier: NCT02430298     History of Changes
Other Study ID Numbers: MLT-MX
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Xerostomia
Mouth Diseases
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants