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

NCT02430298 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-02-24

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Ubon Ratchathani Cancer Hospital, Ubon Ratchathani

    collaborator UNKNOWN

  • General Drugs House Co.,LTD.

    collaborator OTHER

  • Khon Kaen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Thailand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02430298 on ClinicalTrials.gov