Study on Melatonin for Patients with Uveal Melanoma to Prevent Metastasis

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for uveal melanoma, a type of cancer that occurs in the eye. The treatment being tested is Melatonin AGB 5 mg tablets, which is a form of melatonin, a chemical that is naturally produced in the body and is often associated with regulating sleep. The purpose of the study is to determine if taking 20 mg of melatonin every evening for five years can reduce the occurrence of cancer spreading, known as metastasis, in patients with uveal melanoma over a five-year period.

Participants in the study will be randomly assigned to receive either the melatonin treatment or a placebo. The study will be conducted over several years, with regular check-ups to monitor the health and progress of the participants. The main goal is to see how many participants remain free from cancer spread five years after starting the treatment. Additionally, the study will look at overall survival rates, the risk of developing other cancers, and any side effects experienced by participants during the study period.

This trial is an open Phase III study, meaning that both the researchers and participants know which treatment is being administered. The study aims to provide valuable information on whether melatonin can be an effective additional treatment for preventing the spread of uveal melanoma, potentially improving outcomes for patients with this condition.

1 joining the study

Upon joining the study, the participant will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving the study treatment or being in the control group.

2 treatment administration

Participants in the treatment group will receive a medication called melatonin. The specific product used is Melatonin AGB 5 mg tablets.

The dosage is 20 mg of melatonin, which means taking four 5 mg tablets. This medication is taken orally once every evening.

The treatment will continue for a duration of 5 years.

3 monitoring and follow-up

Throughout the study, participants will be monitored regularly to assess their health and any effects of the treatment.

The primary goal is to determine if the treatment reduces the occurrence of cancer spread, known as metastases, over a period of 5 years.

Secondary assessments include overall survival rates and the risk of developing other cancers within the same timeframe.

4 completion of the study

At the end of the 5-year period, participants will undergo a final evaluation to measure the outcomes of the study.

The study aims to conclude by March 31, 2032, with all data collected and analyzed by this date.

Who Can Join the Study?

Must be at least 18 years old.
Must provide written consent to participate in the study.
Must have a diagnosis of uveal melanoma, a type of eye cancer, confirmed by clinical examination or tissue analysis.
Must have a tumor classified as T3d or higher, which corresponds to stage IIIB or higher according to the AJCC TNM system.
Must have a tumor classified as “large” according to modified COMS criteria, meaning the largest diameter is more than 16 mm or the height is more than 8 mm.
If the tumor was treated with brachytherapy (a type of radiation therapy) and has returned, it must have been classified as T2a or higher before the treatment.
Must have a tumor with epithelioid cell type, meaning more than 5 epithelioid cells per high power field (hpf) and more than 90% epithelioid cells in total.
Must have a tumor with low levels of the BAP-1 protein, as determined by a specific test.
Must have a tumor with 9 or more mitoses (a measure of cell division) per 40 hpf.
Must have a 60% or higher risk of developing metastases (spread of cancer) within 5 years, as determined by a validated test, such as “gene expression class 2” or protein level measurement in blood serum.
If already taking melatonin for another condition, must have stopped using it for at least two weeks before joining the study.

Who Cannot Join the Study?

Patients who have any other type of cancer besides uveal melanoma cannot participate.
Patients who are currently receiving treatment for another cancer cannot participate.
Patients with a history of severe allergic reactions to melatonin cannot participate. Melatonin is a hormone that helps regulate sleep.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to take oral medication cannot participate.
Patients with severe liver or kidney disease cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot participate.
Patients with any condition that the study doctors believe would make it unsafe for them to participate cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
St Erik Eye Hospital	Stockholm	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	01.08.2022

Trial locations

Investigated drugs:

Melatonin

Melatonin is a hormone that your body naturally produces, and it helps regulate your sleep-wake cycle. In this clinical trial, melatonin is being used as an additional treatment for uveal melanoma, a type of eye cancer. The researchers want to see if taking melatonin every evening for five years can help reduce the spread of cancer to other parts of the body. By using melatonin, the study aims to explore its potential benefits in preventing cancer from spreading, which could improve long-term outcomes for patients with this type of melanoma.

Investigated diseases:

Uveal melanoma

Uveal Melanoma – Uveal melanoma is a type of cancer that occurs in the eye, specifically in the uvea, which includes the iris, ciliary body, and choroid. It begins when cells in the uvea develop changes in their DNA, leading to uncontrolled growth and the formation of a tumor. As the disease progresses, the tumor can grow larger and may cause symptoms such as visual disturbances or changes in the appearance of the eye. In some cases, the cancer cells can spread to other parts of the body, a process known as metastasis. The progression of uveal melanoma can vary, with some tumors growing slowly while others may advance more rapidly. The disease is relatively rare compared to other types of melanoma, which typically occur on the skin.

Trial ID:

2022-500307-49-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Melatonin for Patients with Uveal Melanoma to Prevent Metastasis

What is this study about?

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