Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Khon Kaen University
Collaborators:
General Drugs House Co.,LTD. General Drugs House Ltd., Bangkok Ubon Ratchathani Cancer Hospital, Ubon Ratchathani