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

NCT02430298 | Completed Phase 2 DMC

• 1 other identifier: MLT-MX
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (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

  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 Outcomes (2)

• 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

• Quality of Life (FACT- H&N Version 4)

  Change from baseline in Trial Outcome Index scores at 7th week

Study Arms (2)

Matched placebo

PLACEBO COMPARATOR

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

Melatonin

ACTIVE COMPARATOR

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

Interventions

Melatonin DRUG

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

Also known as: 20 mg/10 ml melatonin suspensions, 20 mg melatonin gelatin capsule

Melatonin

Matched Placebo DRUG

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

Also known as: 20 mg/10 ml placebo suspensions, 20 mg placebo gelatin capsule

Matched placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead
• Ubon Ratchathani Cancer Hospital, Ubon Ratchathani: collaborator
• General Drugs House Co.,LTD.: collaborator

Study Sites (1)

Ubon Ratchathani Cancer Hospital

Ubon Ratchathani, Changwat Ubon Ratchathani, 34000, Thailand

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Khon Kaen University

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: April 30, 2015
• Study Start: July 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

TH (1)