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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Matched Placebo; Drug: Melatonin

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Ubon Ratchathani, Thailand, 34000
    • Ubon Ratchathani Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Quality of Life (FACT- H&N Version 4)		Change from baseline in Trial Outcome Index scores at 7th week

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Collaborators: General Drugs House Co.,LTD.; Ubon Ratchathani Cancer Hospital, Ubon Ratchathani

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: April 25, 2015
• First Posted (Estimate): April 30, 2015

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis; Xerostomia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: MLT-MX