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Adjuvant Melatonin for Uveal Melanoma

NCT05502900 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-15

No results posted yet for this study

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).

Conditions

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

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.

Sponsors & Collaborators

  • Karolinska Trial Alliance

    collaborator INDUSTRY

  • The Swedish Eye Foundation (Ögonfonden)

    collaborator UNKNOWN

  • The Swedish Society of Medicine

    collaborator OTHER

  • Swedish Cancer Foundation

    collaborator OTHER

  • Gustav Stalhammar

    lead OTHER

Principal Investigators

  • Gustav Stålhammar, MD PhD · St. Erik Eye Hospital and Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-02
Primary Completion
2031-01-01
Completion
2031-01-01

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05502900 on ClinicalTrials.gov