NCT05502900

Adjuvant Melatonin for Uveal Melanoma

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Gustav Stalhammar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

At the time of primary UM diagnosis, about 2 % of patients have radiologically detectable metastases. Within 15 years, this proportion increases to 32-45 % even with successful treatment of the eye. Presumably, this is caused by subclinical dormant micrometastases that most frequently locate to the liver. Once these leave their dormant state and grow into clinically detectable lesions, few effective treatment alternatives are available and the median patient survival is about one year. Several trials have tested interventions for metastatic UM, and in comparison with the greatly improved results for cutaneous melanoma during the last decades, response rates and durations have been low. The AMUM trial will therefore test if adjuvant treatment with Melatonin for 5 years after primary tumor diagnosis can prevent or delay the onset of metastases. 100 patients recently diagnosed with primary UM and found to have a high risk of metastasis will be recruited. The trial is administered from St. Erik Eye Hospital, Stockholm, Sweden, who has a national responsibility for the diagnosis, plaque brachytherapy treatment and histopathological examination of uveal melanomas. This means that all Swedish patients that are diagnosed with uveal melanoma may be considered for inclusion in the trial, regardless of their region of residence. Patients will be screened for eligibility, informed, recruited, randomized, and treated from St. Erik Eye Hospital. Follow-up will be conducted in cooperation with multiple centers all over the country. When informed consent has been obtained, the 100 patients will then be randomized to either treatment with oral tablets of Melatonin (20 mg, taken before bedtime) for 5 years, or to a control group. Both groups will be followed with regular contacts from the investigators, with radiological examinations of the liver every 6 months, and with a blood test at the time of recruitment and then year 2 and 4. When the last patient has taken his or her last tablet after 5 years of treatment, we will examine the primary outcome measure (relative risk of metastasis) and secondary outcome measures (overall survival, survival after development of metastases, number of patients developing other cancers, adverse events (AE) and serious adverse events (SAE)) in the Melatonin vs. control arm. AMUM is an Investigator-Initiated Trial without commercial interests.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-02
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2022-08-16
• Last updated: 2025-05-15

Locations

1 site across 1 country: Sweden