AuthorisedTherapeutic use (Phase IV)Interventional

Treatment of Warthin's tumor: schlerotherapy and its natural course

This study is investigating a treatment option called sclerotherapy for a non-cancerous lump in the salivary glands, known as Warthin's tumour. Sclerotherapy involves injecting a medicine, in this case, Bleomycin Baxter, directly into the lump. The main goal is to see if this treatment can reduce the size of the lump and improve any symptoms, such as discomfort or swelling, that people might be experiencing. Researchers will be observing participants at 6 and 12 months after the treatment to measure these changes. The study is also looking at the natural progression of Warthin's tumour, which means they are comparing the treatment's effects to how the lump typically behaves without this specific intervention. This is a Phase IV study, meaning the treatment is already approved for other uses but is being further studied for Warthin's tumours.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

HUS-Yhtymae

Enrolment target

100

Start

05 Nov 2024

Warthin's tumor

What is this study about?

Warthin's tumour is a non-cancerous (benign) lump that usually grows in the parotid gland, one of the main salivary glands located near your ear. While it's not harmful in the way cancer is, it can sometimes cause symptoms like swelling, a feeling of fullness, or discomfort. People often wonder what their options are for managing these lumps.

This study, called a Phase IV trial, is looking at a treatment called sclerotherapy for Warthin's tumour. Sclerotherapy involves injecting a medication named Bleomycin Baxter directly into the lump. This medication is already safely used for other medical conditions, and this study aims to see if it can be an effective way to treat Warthin's tumour by shrinking it and improving any symptoms you might have. Think of it like a targeted treatment directly to the lump.

The researchers want to understand two main things: how much the lump changes in size and how your symptoms change after receiving this treatment. They will check in with participants at 6 months and 12 months after the treatment to gather this information. By comparing these results to the usual way Warthin's tumours behave, they hope to learn if sclerotherapy is a good option for people with this condition. This research is important because it could offer another way to help people manage their Warthin's tumour and improve their quality of life.

Key takeaways

Study looks at injected treatment for non-cancerous salivary gland lumps.
Aims to shrink the lump and improve symptoms like pain or swelling.
Follow-up appointments at 6 and 12 months to check progress.
Open to adults aged 18 and over, both men and women.
Could offer a new way to manage Warthin's tumour.

Who may be eligible?

To be able to take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, so older adults are also welcome to join.

This study is open to both men and women, as Warthin's tumour can affect anyone regardless of their sex. The main requirement is that you have been diagnosed with a Warthin's tumour that is being considered for treatment.

Specific medical details about your general health and your tumour will be checked by the study doctors to make sure this trial is safe and suitable for you. They will explain everything clearly if you are interested in participating.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Warthin's tumour?
Are you able to attend follow-up appointments for approximately 12 months?
Are you comfortable with the idea of an injection as a treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve receiving the sclerotherapy treatment directly into your Warthin's tumour. You would then have follow-up appointments at 6 months and 12 months after your treatment.

During these follow-up visits, the study team would assess how the size of your tumour has changed and ask you about any symptoms you might have had, such as pain or swelling. They would likely use scans or measurements to check the tumour's volume. The total duration of your active participation, including the treatment and two follow-up checks, would be approximately one year.

Potential risks and benefits

Potential benefits of taking part could include a reduction in the size of your Warthin's tumour and an improvement in any uncomfortable symptoms you currently experience. However, there's also a chance the treatment might not work for you, or your tumour might not change. As with any medical procedure, there are potential risks, such as temporary pain, swelling, or bruising at the injection site. These will be discussed with you in detail by the study team before you decide. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Finland

Common questions

What is Warthin's tumour?

It's a common, non-cancerous lump that usually grows in one of your salivary glands, often near your ear.

What is sclerotherapy?

It's a treatment where a special medicine is injected directly into the lump to help shrink it.

Is the treatment painful?

The team will aim to make you comfortable during the injection, possibly using local anaesthetic, but you might feel some temporary discomfort afterwards.

How long will I be involved in the study?

After receiving the treatment, you'll have follow-up visits at 6 and 12 months, meaning your involvement will last about a year.

What if I change my mind?

You are free to leave the study at any point, and it won't affect your future medical care.