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

Head and Neck Cancer Clinical Trial

Official title:

Topical and Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis and Xerostomia in Head and Neck Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430298
• Other study ID #: MLT-MX
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2014
• Last updated: February 22, 2016
• Start date: July 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Stomatitis
• Xerostomia

Intervention

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
• 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

Locations

Country	Name	City	State
Thailand	Ubon Ratchathani Cancer Hospital	Ubon Ratchathani

Sponsors (3)

Lead Sponsor	Collaborator
Khon Kaen University	General Drugs House Ltd., Bangkok, Ubon Ratchathani Cancer Hospital, Ubon Ratchathani

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to event (occurence of mucositis level 3) during 7 weeks of treatment	No
Secondary	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	Time to event (occurence of mucositis level 3) during 7 weeks of treatment	No
Secondary	Quality of Life (FACT- H&N Version 4)		Change from baseline in Trial Outcome Index scores at 7th week	No