Number of included patients:
Cancer. 1994 Feb 1;73(3):699-701.
randomized study with the pineal hormone melatonin versus supportive
care alone in patients with brain metastases due to solid neoplasms.
Lissoni P, Barni S, Ardizzoia A, Tancini G, Conti A, Maestroni G.
Division of Radiotherapy, San Gerardo Hospital, Milan, Italy.
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.