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

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Matched Placebo; Drug: Melatonin

• Registration Number: NCT02430298
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2015-04-25
• Study First Posted: 2015-04-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matched placebo	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
Melatonin	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

Primary Outcome Measures

Name	Time	Method
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 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

Name	Time	Method
Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale	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
Quality of Life (FACT- H&N Version 4)	Change from baseline in Trial Outcome Index scores at 7th week

Trial Locations

Locations (1)

Ubon Ratchathani Cancer Hospital; 🇹🇭 Ubon Ratchathani, Thailand