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| Name | Class |
|---|---|
| Ubon Ratchathani Cancer Hospital, Ubon Ratchathani | UNKNOWN |
| General Drugs House Co.,LTD. | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of occurrence of xerostomia level 2 or more by using the criteria of CTCAE version 4.0 and the Visual Analogue Scale | Participants will be followed for severity of xerostomia during the treatment period of 7 weeks | Time to event (occurence of mucositis level 3) during 7 weeks of treatment |
| Quality of Life (FACT- H&N Version 4) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ubon Ratchathani Cancer Hospital | Ubon Ratchathani | Changwat Ubon Ratchathani | 34000 | Thailand |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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 |
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| Change from baseline in Trial Outcome Index scores at 7th week |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |