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

Table 1 Study design

Time	Event in clinical routine	Other events for trial subjects
At diagnosis	Clinical examination of the eye. Radiological examination of the thorax and abdomen. Primary treatment^a	Provide information about the trial. Screen participant for inclusion and exclusion criteria Obtain written consent. Give medication instructions. Order blood tests to measure kidney function, electrolytes, and liver function. Prescribe melatonin 20 mg every night for 5 years
1 month	A	Ask about AE and SAE, and about prescription compliance
6 months	B	Ask about AE and SAE, and about prescription compliance
1 year	A + B	Ask about AE and SAE, and about prescription compliance
1.5 years	B	Ask about AE and SAE, and about prescription compliance
2 years	A + B	Ask about AE and SAE, and about prescription compliance. Ordering blood tests to measure kidney function, electrolytes, and liver function
2.5 years	B	Ask about AE and SAE, and about prescription compliance
3 years	A + B	Ask about AE and SAE, and about prescription compliance
3.5 years	B	Ask about AE and SAE, and about prescription compliance
4 years	A + B	Ask about AE and SAE, and about prescription compliance. Order blood tests to measure kidney function, electrolytes, and liver function
4.5 year	B	Ask about AE and SAE, and about prescription compliance
5 years	A + B	End of melatonin treatment. Evaluation of overall survival, metastasis-free survival, and proportion of subjects with metastases^b. Ask about AE and SAE

A = Follow-ups at St. Erik Eye Hospital or at the participant’s local eye clinic. Examination of the eye, for subjects treated with radiation, or of the prosthesis and/or orbit, for subjects treated with enucleation. Follow-up interval ± 4 weeks during the first year and ± 8 weeks after the first year
B = Radiological examination of the liver with ultrasound or computer tomography every 6 months for the first 5 years after diagnosis; can be performed at the participant’s local healthcare clinic. Follow-up interval ± 4 weeks during the first year and ± 8 weeks after the first year
^aPrimary treatment of uveal melanoma in the eye is either enucleation (surgical removal of the eye) or brachytherapy (local radiation therapy of the eye)
^bEvaluation of the proportion of subjects with metastases is performed through data collection via registries, chart documentation, and statistical work. It therefore does not require subjects’ active participation

ISSN: 1745-6215