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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02430298

Enrollment

Registered

2015-04-30

Start date

2013-07-31

Completion date

2015-12-31

Last updated

2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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.

Interventions

DRUGMelatonin

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

DRUGMatched 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026