Adjuvant melatonin for uveal melanoma (AMUM): protocol for a randomized open-label phase III study.
Ruba Kal Omar, Anna Hagström, Gustav Stålhammar
https://pubmed.ncbi.nlm.nih.gov/36966349Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID05502900
Adjuvant Melatonin for Uveal Melanoma: A Randomized Open Phase III Study
Led by Gustav Stalhammar · Updated on 2025-05-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Gustav Stalhammar
Lead Sponsor
K
Karolinska Trial Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
Uveal melanoma (UM) is the most common eye cancer in adults, and nearly half of those diagnosed may develop metastases, which significantly shortens survival. This trial tests whether taking Melatonin tablets after a primary UM diagnosis can prevent or delay metastases. Researchers will compare outcomes between patients treated with Melatonin and those under standard observation, focusing on metastasis development over five years. Participants will be randomly assigned to one of two groups: one taking 20 mg of Melatonin nightly for five years, and a control group receiving no additional treatment beyond standard care. Both groups will undergo regular liver imaging every six months and blood tests at recruitment and during years two and four. The trial is conducted through St. Erik Eye Hospital with follow-up across multiple centers. Throughout the study, participants will have periodic contact with investigators and undergo assessments including liver scans and blood tests. Researchers will track the number of patients developing metastases as the primary outcome, along with survival rates, occurrence of other cancers, and any treatment-related adverse events. The total participation duration is five years, with safety and efficacy closely monitored during this time.
CONDITIONS
Brief Title
Adjuvant Melatonin for Uveal Melanoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Written informed consent given
- Diagnosis of melanoma in the choroid or ciliary body confirmed by clinical or histological methods
- Tumor meets at least one of the following: size category T3d or higher, stage IIIB or IIIC per AJCC version 8, largest basal diameter over 16 mm or apical thickness over 8 mm, recurrence after plaque brachytherapy, epithelioid cell type with more than 5 epithelioid cells per high power field and over 90% of tumor cells epithelioid, low immunohistochemical BAP1 expression, more than 9 mitoses per high power field, or greater than 60% risk of metastases within 5 years by validated prognostic test
- If currently treated with Melatonin, a two-week washout before randomization is required
You will not qualify if you...
- Allergy or oversensitivity to Melatonin or tablet ingredients
- Presence of metastatic disease detectable by radiological or other methods
- Inability to provide informed consent
- Decreased liver function such as liver cirrhosis or hepatitis
- Pregnant women or fertile women of child-bearing potential
- Breastfeeding or planning to breastfeed before trial completion
- History of epilepsy
- Treatment longer than 4 weeks with certain CYP1A2 inhibitors, combined hormonal contraception, hormonal substitution therapy, or other specified drugs
- Primary uveal melanoma diagnosis made more than 12 months prior
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility assessment
Treatment
Duration - 5 years
Participants randomized to the Melatonin group take oral Melatonin tablets (20 mg) every night for 5 years. Participants in the control group do not receive treatment but continue with standard observation.
Regular contacts with investigators and radiological liver examinations every 6 months; blood tests at recruitment, year 2, and year 4
Follow-up
Duration - After 5 years of treatment until study completion
After completing 5 years of treatment or observation, participants continue to be monitored for the development of metastases, survival outcomes, and adverse events.
Regular follow-up visits coordinated with multiple centers across the country
Trial Site Locations
Total: 1 location
1
St. Erik Eye Hospital
Stockholm, Stockholm County, Sweden, 17164
Actively Recruiting
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Research Team
G
Gustav Stålhammar, MD PhD
A
Anna Hagström, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
The rationale for treating uveal melanoma with adjuvant melatonin: a review of the literature.
Anna Hagström, Ruba Kal Omar, Pete A Williams...
https://pubmed.ncbi.nlm.nih.gov/35413810