RecruitingPhase 3NCT05502900

Adjuvant Melatonin for Uveal Melanoma

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

Sponsor

Gustav Stalhammar

Enrollment

100 participants

Start Date

Oct 2, 2022

Study Type

INTERVENTIONAL

Conditions

Uveal Melanoma Eye Cancer, Intraocular Melanoma Uveal Melanoma, Posterior, Medium/Large Size

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether melatonin — commonly known as a sleep aid — can help prevent uveal melanoma (a rare cancer inside the eye) from spreading after initial treatment. It is being tested as an add-on (adjuvant) therapy after standard treatment. **You may be eligible if...** - You are 18 or older with a melanoma inside the eye (in the choroid or ciliary body) - Your tumor is large, high-risk, or has certain genetic features that increase the chance of it spreading - OR your cancer has recurred after prior treatment **You may NOT be eligible if...** - You have known metastatic (spread) disease - You have serious liver or kidney disease - You are pregnant or planning to become pregnant during the study period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMelatonin

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.