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RECRUITING
NCT05502900
PHASE3

Adjuvant Melatonin for Uveal Melanoma

Sponsor: Gustav Stalhammar

View on ClinicalTrials.gov

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).

Official title: Adjuvant Melatonin for Uveal Melanoma: A Randomized Open Phase III Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-10-02

Completion Date

2031-01-01

Last Updated

2025-05-15

Healthy Volunteers

No

Interventions

DRUG

Melatonin

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.

Locations (1)

St. Erik Eye Hospital

Stockholm, Stockholm County, Sweden