Aumkhae Sookprasert1, Nutjaree Pratheepawanit Johns2, Anakapong Phunmanee1, Parichart Pongthai3, Areewan Cheawchanwattana4, Jeff Johns5, Julraht Konsil5, Preeyaporn Plaimee5, Supatra Porasuphatana6, Suthiphan Jitpimolmard1. 1. Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. 2. Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand pnutja@kku.ac.th. 3. Khon Kaen Hospital, Khon Kaen University, Khon Kaen, Thailand. 4. Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand. 5. Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand. 6. Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Pharmacognosy and Toxicology, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
Abstract
BACKGROUND: The MIRCIT trial was a randomized, double-blind, placebo-controlled study of advanced Non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were randomized to receive 10 mg or 20 mg of melatonin or placebo. Assessment of health-related quality of life (HRQoL) was completed at baseline, and at 2, 3 and 7 months. Survival and adverse events were collected. DNA damage marker 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG) was measured during the first three months of chemotherapy. RESULTS: Patients in the melatonin-treated group had better adjusted HRQoL scores, with a slightly significantly better score (2.69 points, 95% confidence interval (CI)=0.01-5.38, p=0.049) being found in social well-being. Median survival was 7.3 months (95% CI=3.42-11.14) without significant difference. A great amont of DNA damage marker was observed in the placebo-treated group, and this was associated with lower survival (r(2)=-0.656, p=0.02), implying the protective effect of melatonin in healthy cells. CONCLUSION:Melatonin in combination with chemotherapy did not affect survival and adverse events of advanced patients with NSCLC, but there was a trend for better HRQoL. Copyright
RCT Entities:
BACKGROUND: The MIRCIT trial was a randomized, double-blind, placebo-controlled study of advanced Non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients were randomized to receive 10 mg or 20 mg of melatonin or placebo. Assessment of health-related quality of life (HRQoL) was completed at baseline, and at 2, 3 and 7 months. Survival and adverse events were collected. DNA damage marker 8-oxo-7,8-dihydro-2'-deoxyguanosine (8-oxodG) was measured during the first three months of chemotherapy. RESULTS:Patients in the melatonin-treated group had better adjusted HRQoL scores, with a slightly significantly better score (2.69 points, 95% confidence interval (CI)=0.01-5.38, p=0.049) being found in social well-being. Median survival was 7.3 months (95% CI=3.42-11.14) without significant difference. A great amont of DNA damage marker was observed in the placebo-treated group, and this was associated with lower survival (r(2)=-0.656, p=0.02), implying the protective effect of melatonin in healthy cells. CONCLUSION:Melatonin in combination with chemotherapy did not affect survival and adverse events of advanced patients with NSCLC, but there was a trend for better HRQoL. Copyright
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