Not yet recruitingPHASE2INTERVENTIONAL

Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy

This study is investigating a new gel, TAR-0520, for people with breast cancer who are having a type of chemotherapy called taxanes. Taxane chemotherapy can sometimes cause uncomfortable side effects like numbness, tingling, and pain in the hands and feet (this is called peripheral neuropathy), and also affect the nails. This research aims to find out if applying the TAR-0520 gel to one hand and one foot can help prevent these side effects from happening in the first place. Participants will apply the gel for a few days during each chemotherapy cycle, and researchers will compare the treated hand and foot to the untreated ones to see if the gel makes a difference. The study also checks how safe the gel is to use.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Tarian Pharma

Enrolment target

Start

01 Sep 2025

Estimated completion

15 Dec 2026

Chemotherapy Induced Peripheral Neuropathy

What is this study about?

When people are treated for breast cancer, they often receive powerful chemotherapy medicines. One type of chemotherapy, called taxanes, is very effective, but it can unfortunately lead to some unwanted side effects. These can include a condition called peripheral neuropathy, which means the nerves in your hands and feet can become damaged, causing numbness, tingling, pain, or strange sensations. Taxane treatment can also sometimes cause problems with your nails.

This study is looking at a new gel, called TAR-0520, to see if it can prevent these side effects from developing. The idea is that by applying the gel directly to the hands and feet, it might protect the nerves and nails from the chemotherapy medicines. We want to find out if this gel truly helps to stop or reduce these problems before they start.

To do this, we'll ask patients to apply the gel to one hand and one foot, leaving the other hand and foot untreated. This way, we can accurately compare whether the gel makes a difference. Researchers will be carefully checking for signs of nerve problems and nail changes in both the treated and untreated areas throughout your chemotherapy treatment.

Key takeaways

The study tests a gel (TAR-0520) for preventing chemotherapy side effects.
It aims to reduce numbness, tingling, and nail issues in breast cancer patients.
You'll apply the gel to one hand and foot, leaving the other side untreated for comparison.
Participation involves regular checks during 12 chemotherapy cycles and a follow-up.
The study is a 'Phase 2a' which means it's an early stage look at safety and effectiveness.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You must have been diagnosed with breast cancer and be planning to start treatment with specific chemotherapy drugs called paclitaxel or docetaxel. You also need to be able to understand what the study involves and give your permission to take part, and be able to apply the gel yourself or have someone help you.

There are some reasons why you might not be able to join. For example, if you've already had taxane chemotherapy or other treatments that cause nerve problems, or if you already have nerve damage from other health conditions like diabetes, alcoholism, or HIV. It's also not suitable if you have certain skin conditions where the gel would be applied, or if you are pregnant, breastfeeding, or planning to get pregnant during the study. Some medications you might be taking could also mean you can't participate, so it’s important to discuss all your current medicines with the study team.

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.

Am I 18 years old or older?
Do I have breast cancer and am starting paclitaxel or docetaxel chemotherapy?
Can I (or someone helping me) apply a gel to my hands and feet twice a day?
Do I have any existing nerve damage from other health issues like diabetes?
Am I pregnant or currently breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in this study over several months. You'll have an initial visit before your chemotherapy starts, then regular visits during your 12 cycles of taxane chemotherapy, and a final follow-up visit about 12 weeks after your last chemotherapy session. In total, there will be 17 visits.

Your main task will be to apply the TAR-0520 gel to one hand and one foot (for example, your left hand and left foot) twice a day for three days during each week you receive chemotherapy. You'll apply the gel yourself, using a glove for the hand that applies it. The gel needs to cover the palms, tops of the hands, fingers, toes, and the skin around your nails. The other hand and foot (your right hand and right foot in the example) will not have any gel applied and will act as a comparison.

Throughout the study, nurses, your oncologist, and specialists will regularly check your hands and feet for any numbness, tingling, or nail problems. You'll also fill out questionnaires, and trained staff will do special tests to measure your nerve function.

Potential risks and benefits

While this gel aims to prevent side effects, there's always a chance it might not work for everyone, or could cause some local skin irritation or other unknown side effects. We are also monitoring how safe the gel is overall. The potential benefit is that the gel could help reduce or prevent nerve damage and nail problems often caused by chemotherapy, which could make your treatment easier to manage. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Institut Paoli-Calmettes
Verified postcode
Marseille, France

Common questions

What is peripheral neuropathy?

It's a condition where the nerves, usually in your hands and feet, get damaged, causing feelings like numbness, tingling, pain, or weakness.

What are taxanes?

Taxanes are a type of chemotherapy drug often used to treat breast cancer.

How long will I be in the study?

You'll be in the study for the duration of your 12 chemotherapy cycles, plus about 12 weeks afterwards for a follow-up, which is several months in total.

Will I know if I'm getting the gel or not?

Yes, you will know you are applying the gel to one hand and one foot. The other hand and foot will definitely not have the gel.

What if I have diabetes?

If you have diabetes, you likely won't be able to join this study, as diabetes can also cause nerve problems that might make it hard to tell if the gel is working.

How to find out more

Janusz M Czernielewski, MD

janusz.czernielewski@tarianpharma.com +33680338274 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.