title: A randomized study with the pineal hormone melatonin versus supportive care alone in patients with brain metastases due to solid neoplasms.
abstract: BACKGROUND
  Unresectable brain metastases remain an untreatable disease. Because of its antitumor cytostatic action and its anticonvulsant effect, the pineal hormone melatonin could constitute a new effective agent in the treatment of brain metastases. The current study was performed to evaluate the effect of melatonin on the survival time in patients with brain metastases due to solid neoplasms.
  
  
  METHODS
  The study included 50 patients, who were randomized to be treated with supportive care alone (steroids plus anticonvulsant agents) or with supportive care plus melatonin (20 mg/day at 8:00 p.m. orally).
  
  
  RESULTS
  The survival at 1 year, free-from-brain-progression period, and mean survival time were significantly higher in patients treated with melatonin than in those who received the supportive care alone. Conversely, steroid-induced metabolic and infective complications were significantly more frequent in patients treated with supportive care alone than in those concomitantly treated with melatonin.
  
  
  CONCLUSIONS
  The pineal hormone melatonin may be able to improve the survival time and the quality of life in patients with brain metastases due to solid tumors.
authors.affiliation: Division of Radiotherapy, San Gerardo Hospital, Milan, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Lissoni
authors.forename: S
authors.initials: S
authors.lastname: Barni
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoia
authors.forename: G
authors.initials: G
authors.lastname: Tancini
authors.forename: A
authors.initials: A
authors.lastname: Conti
authors.forename: G
authors.initials: G
authors.lastname: Maestroni
mesh_terms: D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000401:mortality / Q000556:secondary* / Q000628:therapy*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008550:Melatonin / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011788:Quality of Life; D015996:Survival Rate
chemical_list: D008550:Melatonin