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Study on the Effectiveness of Aprepitant and Fosaprepitant in Preventing Nausea and Vomiting in Children Undergoing Chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of chemotherapy-induced nausea and vomiting (CINV) in children. The trial is investigating the use of two medications: fosaprepitant and aprepitant. These medications are used to help prevent nausea and vomiting that can occur after chemotherapy, which is a treatment for cancer. The study aims to find out if using these medications for a longer period can better prevent nausea and vomiting compared to the current standard treatment duration.

Participants in the study will receive either the medication or a placebo during their chemotherapy treatment. The study is designed in a way that each child will receive both the medication and the placebo at different times, allowing researchers to compare the effects directly. The trial will last for a maximum of eight days during each chemotherapy cycle, and the children will act as their own control, meaning they will receive both treatments in different cycles.

The main goal of the study is to see if extending the use of fosaprepitant and aprepitant can prevent nausea and vomiting more effectively in the days following chemotherapy. The study will also look at the safety of using these medications for a longer time and how they affect the children's experience of nausea and vomiting. This research is important for improving the quality of life for children undergoing chemotherapy by reducing the discomfort caused by nausea and vomiting.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility criteria are confirmed. This includes age, health status, and previous treatments.
A negative pregnancy test is required for female patients of childbearing potential.
Step 2
Initial chemotherapy cycle
The first cycle of chemotherapy begins. This cycle lasts up to 8 days.
During this cycle, a 3-day regimen of aprepitant is administered orally in the form of capsules.
Step 3
Placebo administration
After the initial 3-day regimen of aprepitant, a placebo is administered for the remaining days of the chemotherapy cycle.
Step 4
Second chemotherapy cycle
A second cycle of chemotherapy, similar to the first, is conducted. This cycle also lasts up to 8 days.
During this cycle, fosaprepitant is administered intravenously for the entire duration of the chemotherapy cycle.
Step 5
Monitoring and assessment
Throughout both cycles, the response to the treatment is monitored. This includes checking for nausea and vomiting.
The effectiveness of the treatment is assessed using tools like the Pediatric Nausea Assessment Tool (PeNAT) and the Baxter Retching Faces (BARF).
Step 6
Completion of study participation
After completing both chemotherapy cycles, the study participation concludes.
Final assessments are conducted to evaluate the overall response to the treatment and any side effects experienced.

Who can join the trial?

23 criteria

Age must be between 6 months and 18 years at the time of joining the study.
Patients should not receive chemotherapy that includes **corticosteroids** (a type of medication) during the study.
Patients older than 16 years need a **Karnofsky score** of 60 or more, and those 16 years or younger need a **Lansky Play performance score** of 60 or more. These scores measure how well a patient can perform daily activities.
Patient must have a life expectancy of at least 3 months.
Patients must not use **antiemetic** (anti-nausea) treatment within 48 hours before starting the study treatment.
No use of **CYP3A4 substrates/inhibitors** (certain medications) within 7 days, or **CYP3A4 inducers** within 30 days of treatment.
**Serum creatinine** (a kidney function test) must be no more than 1.5 times the normal limit for their age.
**AST and ALT** (liver function tests) must be no more than 5 times the normal limit.
**Total bilirubin** (a liver function test) must be no more than 1.5 times the normal limit.
No history of **QT prolongation** (a heart rhythm condition).
Female patients who can have children must have a negative pregnancy test before joining the study.
Patients must not receive radiation therapy to the abdomen or pelvis in the week before treatment.
Female patients with infants must agree not to breastfeed while on this study.
Male and female patients who can have children must agree to use a highly effective method of birth control during the study.
Patients must not have had a severe allergic reaction to any of the study drugs in the past.
Patients must not have any stomach or intestinal disease that could affect how the medication is absorbed.
Patients must not use **benzodiazepines** or **opioids** (types of medications) started within 48 hours before treatment, except for single doses of triazolam, temazepam, or midazolam.
Patients on long-term benzodiazepine or opioid therapy can continue if it started at least 48 hours before the study drug is given.
Patients on long-term therapy with certain drugs like warfarin, acenocoumarol, tolbutamide, or phenytoin should be monitored closely during and after treatment with (fos)aprepitant.
Patients must have a documented **malignancy** (cancer).
Patients need to receive chemotherapy that is moderate or highly likely to cause nausea and vomiting for at least 4 days.
Chemotherapy schedules must include two similar courses, which do not have to be consecutive.
No primary or metastatic **CNS malignancy** (cancer in the brain or spinal cord) causing nausea or vomiting.

Who cannot join the trial?

6 criteria

Patients who are not experiencing delayed chemotherapy-induced nausea and vomiting (CINV). This is a condition where nausea and vomiting occur after receiving chemotherapy.
Patients who are not receiving moderate or highly emetogenic chemotherapy. This type of chemotherapy is known to cause nausea and vomiting.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
Patients who are currently participating in another clinical trial that might interfere with this study.

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Investigated drugs

Fosaprepitant: This medication is used to prevent nausea and vomiting caused by chemotherapy. It works by blocking the signals in the brain that trigger nausea and vomiting. In this trial, the researchers are studying whether extending the use of fosaprepitant throughout the entire course of chemotherapy, instead of just the first three days, can better prevent these side effects in children undergoing treatment.

What is already known about the treatment

Fosaprepitant – Fosaprepitant is administered intravenously and is used to prevent nausea and vomiting caused by chemotherapy. It is currently being studied in clinical trials to determine the optimal duration of its use in children undergoing chemotherapy. The main therapeutic indication is to prevent delayed chemotherapy-induced nausea and vomiting (CINV). At the molecular level, fosaprepitant works by blocking the neurokinin-1 (NK1) receptors in the brain, which are involved in triggering nausea and vomiting. It belongs to the pharmacological class of NK1 receptor antagonists.

Investigated diseases

Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) – This condition occurs in patients undergoing chemotherapy, where nausea and vomiting begin more than 24 hours after the treatment. It is a common side effect of chemotherapy, especially with drugs that are highly emetogenic, meaning they are likely to cause vomiting. The symptoms can last for several days and may significantly affect a patient's quality of life. Delayed CINV is distinct from acute CINV, which occurs within the first 24 hours after chemotherapy. The condition is often managed by using medications that prevent nausea and vomiting, but the focus here is on understanding its progression and impact.