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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Melatonin
Matched Placebo
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ubon Ratchathani Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Matched placebo

Melatonin

Arm Description

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: 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

Outcomes

Primary Outcome Measures

Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores
Participants will be followed for severity of mucositis during the treatment period of 7 weeks

Secondary Outcome Measures

Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale
Participants will be followed for severity of xerostomia during the treatment period of 7 weeks
Quality of Life (FACT- H&N Version 4)

Full Information

First Posted
January 28, 2014
Last Updated
February 22, 2016
Sponsor
Khon Kaen University
Collaborators
Ubon Ratchathani Cancer Hospital, Ubon Ratchathani, General Drugs House Co.,LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT02430298
Brief Title
Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients
Official Title
Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
Collaborators
Ubon Ratchathani Cancer Hospital, Ubon Ratchathani, General Drugs House Co.,LTD.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Matched placebo
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Melatonin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Melatonin
Other Intervention Name(s)
20 mg/10 ml melatonin suspensions, 20 mg melatonin gelatin capsule
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Matched Placebo
Other Intervention Name(s)
20 mg/10 ml placebo suspensions, 20 mg placebo gelatin capsule
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of occurrence of mucositis level 3 or more by using the criteria of CTCAE version 4.0, World Health Organization scale and MTSscores
Description
Participants will be followed for severity of mucositis during the treatment period of 7 weeks
Time Frame
Time to event (occurence of mucositis level 3) during 7 weeks of treatment
Secondary Outcome Measure Information:
Title
Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale
Description
Participants will be followed for severity of xerostomia during the treatment period of 7 weeks
Time Frame
Time to event (occurence of mucositis level 3) during 7 weeks of treatment
Title
Quality of Life (FACT- H&N Version 4)
Time Frame
Change from baseline in Trial Outcome Index scores at 7th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ubon Ratchathani Cancer Hospital
City
Ubon Ratchathani
ZIP/Postal Code
34000
Country
Thailand

12. IPD Sharing Statement

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

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