Adjuvant Melatonin for Uveal Melanoma

Summary

Uveal melanoma (UM) is the most common type of cancer inside the eyes of adults. Almost half of all patients diagnosed with UM will eventually develop metastases. Once metastases occur, the median patient survival is short. In this trial, we will test if treatment with Melatonin after primary tumor diagnosis can prevent or delay the development of metastases. 100 patients diagnosed with primary UM will be randomized to either treatment with Melatonin tablets (20 mg at night), or to a control group. Both groups will be followed for 5 years. At 5 years, the number of patients that have developed metastases in the Melatonin and control groups will be compared (primary outcome measure).

Timeline

Start

2022-10-02

Primary completion

2031-01-01

Completion

2031-01-01

Publications

• Background Kal Omar R, Hagstrom A, Stalhammar G. Adjuvant melatonin for uveal melanoma (AMUM): protocol for a randomized open-label phase III study. Trials. 2023 Mar 26;24(1):230. doi: 10.1186/s13063-023-07245-9.
• Background Hagstrom A, Kal Omar R, Williams PA, Stalhammar G. The rationale for treating uveal melanoma with adjuvant melatonin: a review of the literature. BMC Cancer. 2022 Apr 13;22(1):398. doi: 10.1186/s12885-022-09464-w.

Drugs

Indications