Randomized Phase III Trial of Melatonin Tablets to Prevent Metastases in Adults with Uveal Melanoma

What this Trial Is About

Uveal melanoma UM is the most common eye cancer in adults, and nearly half of those diagnosed may develop metastases, which significantly shortens survival. This trial tests whether taking Melatonin tablets after a primary UM diagnosis can prevent or delay metastases. Researchers will compare outcomes between patients treated with Melatonin and those under standard observation, focusing on metastasis development over five years. Participants will be randomly assigned to one of two groups one taking 20 mg of Melatonin nightly for five years, and a control group receiving no additional treatment beyond standard care. Both groups will undergo regular liver imaging every six months and blood tests at recruitment and during years two and four. The trial is conducted through St. Erik Eye Hospital with follow-up across multiple centers. Throughout the study, participants will have periodic contact with investigators and undergo assessments including liver scans and blood tests. Researchers will track the number of patients developing metastases as the primary outcome, along with survival rates, occurrence of other cancers, and any treatment-related adverse events. The total participation duration is five years, with safety and efficacy closely monitored during this time.

Adjuvant Melatonin for Uveal Melanoma