Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIa, Multicenter, Randomized, Controlled, Open label Study to Evaluate the Efficacy of SENS-401 to Prevent the Ototoxicity induced by Cisplatin in Adult Subjects with a Neoplastic Disease

This research study is looking into a new medicine called SENS-401. It's for adult cancer patients who are being treated with cisplatin chemotherapy. Cisplatin is a powerful cancer drug, but one of its side effects can be hearing loss. The main goal of this study is to see if SENS-401 can help prevent this hearing damage. Researchers will be carefully checking participants' hearing before and after they take cisplatin, and comparing those who receive SENS-401 with those who don't. This is an important step to find ways to make cancer treatments more bearable for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sensorion

Enrolment target

Start

20 Aug 2024

Cisplatine induced hearing loss

What is this study about?

When people are treated for cancer, doctors often use strong medicines like cisplatin. While cisplatin is very good at fighting cancer, it can sometimes damage the delicate parts of the ear, leading to hearing problems. This can be a really difficult side effect for patients to deal with.

This study is trying to find a way to protect hearing. Researchers are investigating a new medicine called SENS-401 (also referred to as arazasetron besylate). They want to know if giving SENS-401 to patients alongside their cisplatin chemotherapy can stop the hearing loss from happening. It’s like trying to put a shield around the ears to guard them from the chemotherapy’s effects.

The main thing the doctors will be measuring is how a person's hearing changes over time. They will test hearing before treatment starts and again several weeks after the last cisplatin dose. By comparing the hearing of people who take SENS-401 with those who don't, they hope to see if this new medicine makes a real difference in preventing hearing difficulties.

Key takeaways

This study is testing a new drug, SENS-401, to prevent hearing loss caused by cisplatin (a cancer medicine).
It's for adult cancer patients currently receiving or about to receive cisplatin chemotherapy.
The main goal is to see if SENS-401 can protect hearing as measured by specific hearing tests.
Participation involves taking SENS-401, having regular hearing tests, and other health checks.
Potential benefit: reduced risk of hearing problems. Potential risks: possible side effects from SENS-401.
You can stop participating at any time without impacting your usual medical care.

Who may be eligible?

This study is looking for adult patients who have cancer and are going to be treated with cisplatin chemotherapy. Only people aged 18 years and older can take part, and it's open to both men and women.

There will be other specific health requirements that your doctor will need to check. For example, they will need to make sure your overall health is suitable for the study and that you are not on other medications that might interfere with SENS-401.

Your cancer doctor will be able to tell you if you meet all the necessary criteria to be considered for this study.

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?
Are you currently receiving or planning to receive cisplatin chemotherapy for cancer?
Are you willing to have regular hearing tests and other health checks?
Are you able to attend all required study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine, SENS-401, while you are also having your cisplatin chemotherapy. This will involve regular visits to the hospital or clinic for your cancer treatment, and during these visits, study staff will also check on your health and progress.

Before you start, and at several points during and after your treatment, you will have hearing tests (called audiograms). These tests are painless and involve listening to different sounds through headphones. They help doctors measure your hearing accurately. You will also have various health checks, such as blood tests, to make sure you are doing well. The study involves follow-up for a period after your last cisplatin treatment to check on your long-term hearing and overall health.

Potential risks and benefits

Taking part in this study may offer a potential benefit: there's a chance that SENS-401 could help protect your hearing from the damaging effects of cisplatin. However, there's no guarantee, and SENS-401 may not work for everyone. As with any new medicine, there's also a chance of side effects, which the study doctors will carefully monitor. You will be told about all known or potential risks before you decide to join. Remember, taking part in any clinical study is always voluntary, and you have the right to withdraw at any time without affecting your usual 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
France

Common questions

What is cisplatin?

Cisplatin is a chemotherapy medicine often used to treat various types of cancer. It works by stopping cancer cells from growing and dividing.

Why is this study important?

This study is important because it's looking for a way to prevent hearing loss, a common and difficult side effect for people taking cisplatin chemotherapy, helping to improve their quality of life.

Will I know if I'm getting the new medicine?

Yes, this is an 'open-label' study, which means both you and your study doctor will know if you are receiving SENS-401 or standard care.

What is an audiogram?

An audiogram is a simple and non-painful hearing test where you listen to different sounds through headphones, and it helps measure how well you hear at various pitch levels.

Does taking part affect my cancer treatment?

No, your cancer treatment with cisplatin will continue as planned. This study is designed to add SENS-401 to your existing treatment, if you agree to participate.