title: Melatonin in patients with cancer receiving chemotherapy: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  The MIRCIT trial was a randomized, double-blind, placebo-controlled study of advanced Non-small cell lung cancer (NSCLC).
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Aumkhae
authors.initials: A
authors.lastname: Sookprasert
authors.affiliation: 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.
authors.forename: Nutjaree Pratheepawanit
authors.initials: NP
authors.lastname: Johns
authors.affiliation: Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Anakapong
authors.initials: A
authors.lastname: Phunmanee
authors.affiliation: Khon Kaen Hospital, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Parichart
authors.initials: P
authors.lastname: Pongthai
authors.affiliation: 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.
authors.forename: Areewan
authors.initials: A
authors.lastname: Cheawchanwattana
authors.affiliation: Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Jeff
authors.initials: J
authors.lastname: Johns
authors.affiliation: Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Julraht
authors.initials: J
authors.lastname: Konsil
authors.affiliation: Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Preeyaporn
authors.initials: P
authors.lastname: Plaimee
authors.affiliation: Melatonin Research Group, Khon Kaen University, Khon Kaen, Thailand Division of Pharmacognosy and Toxicology, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Supatra
authors.initials: S
authors.lastname: Porasuphatana
authors.affiliation: Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
authors.forename: Suthiphan
authors.initials: S
authors.lastname: Jitpimolmard
mesh_terms: D000080242:8-Hydroxy-2'-Deoxyguanosine; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000627:therapeutic use; D004249:DNA Damage / Q000235:genetics; D003849:Deoxyguanosine / Q000031:analogs & derivatives / Q000032:analysis; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008550:Melatonin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D000975:Antioxidants; D010919:Placebos; D000080242:8-Hydroxy-2'-Deoxyguanosine; D003849:Deoxyguanosine; D008550:Melatonin; D002945:Cisplatin
keywords: 8-oxo-7,8-dihydro-2’-deoxyguanosine; 8-oxodG; Melatonin; cancer; chemotherapy; clinical trial; quality of life