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Completed

NCT Number: NCT02430298

Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia 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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ubon Ratchathani Cancer Hospital

Ubon Ratchathani, Changwat Ubon Ratchathani, 34000, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: 20 mg/10 ml melatonin suspensions, 20 mg melatonin gelatin capsule

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

Other names: 20 mg/10 ml placebo suspensions, 20 mg placebo gelatin capsule

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

    Time frame: 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 outcomes

  1. Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale

    Time frame: 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

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

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

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • General Drugs House Co.,LTD.
  • Ubon Ratchathani Cancer Hospital, Ubon Ratchathani

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 30, 2015
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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