All studies
Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The effect of oral folinic acid rescue therapy on pemetrexed induced neutropenia and other toxicity: A randomized open-label trial.

This study, called "The effect of oral folinic acid rescue therapy on pemetrexed induced neutropenia and other toxicity," is investigating how a drug called Rescuvolin (15mg tablets) might reduce side effects for people receiving a specific type of cancer treatment. The main focus is on a common side effect called neutropenia, which means having a low count of certain white blood cells. This can increase the risk of infection. The study aims to find out if Rescuvolin can help keep these white blood cells at a healthier level around 8-10 days after cancer treatment. It's for adults with conditions like non-small cell lung cancer, mesothelioma, or thymoma. By understanding this, we hope to improve the experience of people undergoing cancer treatment and help them manage side effects more effectively.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Amphia Hospital
Enrolment target
50
Start
18 Jan 2023

What is this study about?

When people with certain types of cancer, like non-small cell lung cancer, mesothelioma, or thymoma, receive chemotherapy, they might experience side effects. One common and important side effect is called neutropenia. This means that the treatment causes a drop in a type of white blood cell called neutrophils. These cells are really important for fighting off infections, so having too few of them can make you more likely to get ill.

This study is looking at a medicine called Rescuvolin, which comes in 15mg tablets. We want to see if taking Rescuvolin can help to prevent or reduce this drop in white blood cells. Specifically, we'll be checking how many neutrophils people have in their blood around 8 to 10 days after their cancer treatment. The idea is to see if Rescuvolin can act as a kind of 'rescue therapy' to help protect these important blood cells.

Apart from looking at white blood cell counts, the study will also check for other things. This includes how severe any neutropenia is, levels of a substance in the blood called homocysteine, and how well the cancer treatment is working overall. We'll also keep an eye on whether people need to stop their treatment, or have their doses changed or delayed, as this can sometimes happen due to side effects. By carefully studying all these aspects, we hope to learn if Rescuvolin can make cancer treatment more manageable and safer for patients.

Key takeaways

  • This study investigates if Rescuvolin helps reduce white blood cell side effects from cancer treatment.
  • It focuses on people with non-small cell lung cancer, mesothelioma, or thymoma.
  • The main goal is to reduce neutropenia (low white blood cell count).
  • Participation involves taking Rescuvolin tablets and having regular blood tests.
  • It aims to improve how patients tolerate their cancer therapy.
  • You can withdraw from the study at any time.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning people of all adult ages can be considered. The study is open to both men and women.

Importantly, you must have one of the specific cancer types that the study is focusing on. These are non-small cell lung cancer, mesothelioma, or thymoma.

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.

  1. Are you 18 years old or older?
  2. Do you have non-small cell lung cancer?
  3. Do you have mesothelioma?
  4. Do you have thymoma?
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 study medicine, Rescuvolin, in tablet form. You'll continue with your usual cancer treatment as planned by your doctors. Throughout the study, you'll have blood tests to check your neutrophil count (a type of white blood cell) around 8-10 days after your cancer treatment. There will also be other blood tests at the beginning to check homocysteine levels.

Your doctors will continue to monitor how well your cancer treatment is working through scans after cycles 2 and 4. We will also track any changes to your treatment, such as if doses are changed, delayed, or stopped. The total time you'll be involved in the study will depend on your individual cancer treatment plan.

Potential risks and benefits

Taking part in this study might offer some potential benefits by helping to reduce side effects like low white blood cell counts, which could make your cancer treatment more manageable. However, like all medicines, Rescuvolin can have its own risks and side effects, which will be fully explained by your doctor. It's important to remember that you are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is neutropenia?

Neutropenia means having too few of certain white blood cells (called neutrophils). These cells are very important for fighting off infections.

What is Rescuvolin?

Rescuvolin is a medicine in tablet form that this study is testing to see if it can help reduce side effects of cancer treatment.

Which cancers is this study for?

This study is for people with non-small cell lung cancer, mesothelioma, or thymoma.

Will my cancer treatment change if I join?

No, your planned cancer treatment will continue as normal. This study is about adding Rescuvolin to see if it helps with side effects.

Who can take part?

Anyone aged 18 or older with one of the specific cancer types mentioned can potentially take part, regardless of gender.

How to find out more

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

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.