At a glance
ClinicalIndex Comparison Record- ✓Patient age ≥18 years
- ✓Written informed consent provided
- ✓Melanoma originating in choroid or ciliary body
- ✓Tumor size T3d or higher, or stage IIIB/IIIC (AJCC v8)
- ✕Allergy or hypersensitivity to melatonin or excipients
- ✕Metastatic disease (radiologically detectable)
- ✕Unable to provide informed consent
- ✕Decreased liver function (cirrhosis, hepatitis)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adjuvant Melatonin for Uveal Melanoma: A Randomized Open Phase III Study
In Brief
A Phase 3 clinical trial evaluating Melatonin for Uveal Melanoma and 2 related conditions. Currently recruiting, targeting 100 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
White round tablets, each with a dose of 5 mg Melatonin. 4 tablets taken simultaneously at night. Tablets can be crushed and/or taken with a glass of water if the patient wish.