Adjuvant melatonin for uveal melanoma (AMUM): protocol for a randomized open-label phase III study

Area of Science:

• Ophthalmology
• Oncology
• Pharmacology

Background:

• Uveal melanoma is the most common primary intraocular tumor in adults, with high metastasis rates and poor survival post-detection.
• Current treatments for uveal melanoma (enucleation, brachytherapy) lack adjuvant therapies to prevent metastasis.
• Melatonin, a hormone with anti-cancer properties, has shown promise in other cancer types with minimal side effects.

Purpose of the Study:

• To evaluate the efficacy of 5-year adjuvant melatonin treatment in preventing metastases in non-metastatic uveal melanoma patients.
• To assess the impact of melatonin on overall survival and the risk of developing secondary cancers.
• To compare the incidence of adverse events between melatonin treatment and standard follow-up.

Main Methods:

• An open-label, prospective, 5-year randomized clinical trial (RCT) involving 100 patients with non-metastatic uveal melanoma.
• Participants are randomized to receive either adjuvant melatonin (20 mg daily) or standard follow-up.
• Primary outcome: relative risk of developing metastases at 5 years; secondary outcomes: overall survival, secondary cancer risk, and adverse events.

Main Results:

• The study is ongoing, and results are not yet available.
• The primary outcome is the relative risk of developing metastases 5 years post-randomization.
• Secondary outcomes include overall survival and adverse event profiles.

Conclusions:

• Melatonin exhibits anti-cancer properties, including immune support, anti-angiogenesis, apoptosis induction, and antioxidant effects.
• Previous studies suggest melatonin is safe and effective at similar doses, particularly in advanced cancers.
• Melatonin's potential benefits, low toxicity, and availability make it a promising candidate for adjuvant therapy in uveal melanoma.