DAVINCY trial: optimal Duration of (fos)Aprepitant prophylaxis for nausea and Vomiting INduced by ChemotherapY in children: a double-blind placebo-controlled crossover randomized phase III trial.
The DAVINCY trial is a study for children receiving chemotherapy. Chemotherapy can sometimes make children feel or be sick, which is known as Chemotherapy-Induced Nausea and Vomiting (CINV). This study is investigating a medicine called aprepitant, which is given to help prevent these symptoms. Researchers want to find out the best way and duration to give this medicine to children so they feel as well as possible after their chemotherapy. They are comparing different amounts and ways of giving aprepitant with a dummy medicine (placebo) to see which is most effective at preventing sickness and vomiting, particularly in the days after chemotherapy has finished. The aim is to help more children avoid these unpleasant side effects.
At a glance
What is this study about?
Chemotherapy is a very important treatment for many children with cancer. However, one common and challenging side effect can be feeling sick or actually being sick, often called Chemotherapy-Induced Nausea and Vomiting (CINV). This can happen during treatment and sometimes in the days following chemotherapy, which doctors call the 'delayed phase'. This trial, called DAVINCY, is focused on finding the best way to help children avoid these unpleasant feelings.
The study is looking at a specific medicine called aprepitant (which might also be given as fosaprepitant). This medicine is already used to help prevent sickness, but the researchers want to understand if giving it for a longer period of time, or in different ways, works even better for children. They are comparing the standard way of giving the medicine with a placebo – which looks like the real medicine but doesn't contain any active ingredients – to truly see the difference it makes.
The main goal is to see how many children can go through their chemotherapy course without feeling sick, being sick, or needing extra medicines to control these symptoms, especially in the 24 to 72 hours after their final chemotherapy dose. They will also look at how children feel during and immediately after chemotherapy, track any side effects from the study medicine, and even consider if the prolonged use is cost-effective for the healthcare system. All these steps are to help improve the quality of life for children undergoing cancer treatment.
Key takeaways
- The DAVINCY trial aims to reduce sickness and vomiting in children having chemotherapy.
- It tests different ways of giving a medicine called aprepitant to see what works best.
- Participation involves receiving either aprepitant or a dummy medicine, with close monitoring.
- The study helps improve comfort and quality of life for children with cancer.
- You can withdraw from the study at any time without affecting your child's care.
Who may be eligible?
This study is open to children of all ages who are receiving chemotherapy. Both boys and girls can take part. The specific type of chemotherapy a child is receiving is important, as the study focuses on chemotherapy known to often cause sickness.
More detailed criteria about a child's medical history, current health, and specific chemotherapy plan will be discussed by the medical team. They will ensure that the study is a suitable and safe option for each individual child.
It's important to remember that joining a clinical trial is a big decision, and the medical team will explain everything fully to the child and their parents or guardians.
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.
- Is my child undergoing chemotherapy?
- Does my child's chemotherapy often cause sickness?
- Is my child able to participate in regular check-ups?
- Are we comfortable with the possibility of receiving a dummy medicine?
What does participation involve?
If your child takes part in the DAVINCY trial, they will receive either the study medicine (aprepitant/fosaprepitant) or a placebo, which is a dummy medicine. This will be given during their chemotherapy treatment and possibly for a longer period afterwards, following a specific plan. Neither you nor your doctor will know whether your child is receiving the active medicine or the placebo – this is called 'double-blind' and helps ensure the results are accurate. At some point in the trial, your child might switch to receive the other treatment, meaning they would get the active medicine if they started on placebo, or vice versa. This is called a 'crossover' design.
Throughout the study, the medical team will carefully monitor your child for any signs of sickness or vomiting, and ask about how they are feeling. They might use special tools or questionnaires designed for children to assess nausea. They will also track if your child needs any 'rescue medication' (extra medicine to help with sickness). Blood tests might be taken to see how the study medicine moves through the body. The doctors will also keep a close eye on your child for any side effects. The total duration of participation will depend on your child's chemotherapy cycle, but assessments will typically focus on the period during and immediately after chemotherapy.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is CINV?
CINV stands for Chemotherapy-Induced Nausea and Vomiting. It's when children feel or are sick because of their cancer treatment.
What is aprepitant?
Aprepitant is a medicine used to help prevent children from feeling or being sick after chemotherapy. This study is looking at how best to give it.
What does 'double-blind' mean?
It means neither you, your child, nor your doctors will know if your child is getting the actual medicine or a dummy medicine (placebo). This helps make the study fair.
Will my child get the real medicine?
Because it's a 'crossover' study, if your child starts on the dummy medicine, they will likely get the active medicine at another point, and vice-versa, to compare effects.
What if my child feels too sick during the study?
The medical team will closely monitor your child, and they can receive extra medicines ('rescue medication') if needed to help them feel better.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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