RecruitingPHASE2INTERVENTIONAL

Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL

This study is investigating a dietary supplement called OnLife to see if it can help prevent nerve damage, a common side effect, in breast cancer patients receiving a chemotherapy drug called PACLITAXEL. Nerve damage, or neuropathy, can sometimes lead to chemotherapy doses being lowered or stopped early. The researchers hope that by using OnLife, patients might experience fewer nerve problems, which could help them complete their full course of treatment more comfortably and potentially improve the overall effectiveness against their cancer, ultimately enhancing their quality of life. The study compares OnLife to a placebo, which is a dummy pill, to understand its effects better. It's for adults aged 18 and over who are undergoing this specific type of breast cancer treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Georges Francois Leclerc

Enrolment target

Start

12 Apr 2024

Estimated completion

30 Jun 2026

Breast Cancer

What is this study about?

When people have breast cancer, they sometimes need a type of chemotherapy called PACLITAXEL. While this medicine is very effective at fighting cancer, it can sometimes cause a side effect called neuropathy. This means it can affect nerves, leading to symptoms like numbness, tingling, or pain, usually in the hands and feet. These nerve problems can be quite uncomfortable and, in some cases, might even mean that doctors need to reduce the amount of chemotherapy given or stop it earlier than planned.

This study is looking into a dietary supplement called OnLife. The researchers want to see if taking OnLife can help prevent or reduce these nerve problems when patients are havingPACLITAXEL chemotherapy. They believe that if OnLife works, it could help patients feel better during their treatment and make it easier for them to complete their full chemotherapy course. Completing the full course of chemotherapy is important as it can improve how well the treatment works against the cancer.

The study will compare people who take OnLife with a group who take a placebo, which looks like OnLife but contains no active ingredients. This helps the researchers understand if any improvements are truly due to OnLife or something else. By potentially reducing side effects and helping patients finish their treatment, this study aims to improve both the chances of treatment success and the day-to-day well-being of people with breast cancer.

Key takeaways

This study investigates if a supplement can reduce chemotherapy side effects for breast cancer.
It aims to prevent nerve damage (neuropathy) caused by PACLITAXEL.
The study compares OnLife supplement with a dummy pill (placebo).
Success could mean fewer chemotherapy reductions and better quality of life.
Participation involves taking tablets and completing questionnaires.

Who may be eligible?

To join this study, you would generally need to be an adult (18 years or older) with breast cancer who is about to start receiving PACLITAXEL chemotherapy once a week for 12 weeks. You should also be well enough to carry out most of your daily activities, and your doctors will assess your overall health to make sure you can safely take part.

There are also some specific things that would mean you couldn't join the study. For example, if you've already started PACLITAXEL chemotherapy, or if you have certain other health conditions like diabetes, or nerve problems that you had before starting chemotherapy, you wouldn't be able to participate. If you have any known allergies to fish oil, which is in the study supplement, or if you are pregnant or breastfeeding, the study wouldn't be suitable for you. You must also be able to swallow tablets easily and be willing to follow all the study instructions and fill out questionnaires.

This study is specifically for women, and careful consideration is given to women who could become pregnant, requiring them to use effective contraception during the study. It's important to remember that all participants must be able to understand the study, give their permission to take part, and be able to attend follow-up appointments.

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.

Have I been diagnosed with breast cancer?
Am I due to start weekly PACLITAXEL chemotherapy for 12 weeks?
Am I over 18 years old?
Do I have any existing nerve problems or diabetes?
Am I currently pregnant or breastfeeding?
Can I swallow tablets easily and attend all appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to one of two groups. One group will receive the OnLife supplement, and the other will receive a placebo (a dummy pill). You wouldn't know which one you're taking. You would start taking the tablets a few days before your PACLITAXEL chemotherapy begins, and you'd continue taking them for about a month after your chemotherapy finishes.

Throughout the study, you would continue with your regular weekly PACLITAXEL chemotherapy as planned by your doctors. You would also need to complete several questionnaires to help the study team understand how you're feeling and whether you're experiencing any nerve problems. There will be planned visits to your clinic for assessments and follow-up. The exact duration of your participation would cover the period of your chemotherapy, plus an additional month for the supplement, along with any necessary follow-up appointments.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits, such as receiving a supplement that might help reduce chemotherapy-related nerve problems, which could improve your comfort and ability to complete your treatment. However, there's no guarantee that you'll receive the active OnLife supplement, as some participants receive a placebo. Every treatment and supplement carries potential risks, including side effects, and while OnLife is a dietary supplement, the study will carefully monitor your health. You will be told about any known risks for OnLife or the placebo. It's very important to remember that joining a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre Georges François Leclerc
Verified postcode
Dijon, France· Recruiting

Common questions

What is PACLITAXEL?

PACLITAXEL is a common chemotherapy drug used to treat breast cancer.

What is neuropathy?

Neuropathy is a type of nerve damage that can cause symptoms like numbness, tingling, or pain, often in the hands and feet.

What is OnLife?

OnLife is a dietary supplement being tested in this study to see if it can help prevent nerve problems caused by PACLITAXEL.

Why is there a placebo group?

The placebo group helps researchers compare results and determine if OnLife is truly effective, or if improvements might be due to other factors.

Can I choose which group I'm in?

No, participants are randomly assigned to either the OnLife group or the placebo group, meaning it's decided by chance.

How to find out more

Didier MAYEUR, Doctor

dmayeur@cgfl.fr 03 80 73 75 00 Official trial record

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