Ongoing Clinical Trials for Vomiting
There are currently 2 ongoing clinical trials investigating ways to prevent and manage vomiting in different patient populations. These studies focus on using medications called aprepitant and fosaprepitant to help patients experiencing nausea and vomiting related to chemotherapy treatment and after weight-loss surgery.
Clinical trial locations
- Estonia
- Netherlands
Study on the Effectiveness of Aprepitant and Fosaprepitant in Preventing Nausea and Vomiting in Children Undergoing Chemotherapy
This trial is investigating whether extending the use of two medications can better prevent nausea and vomiting in children receiving chemotherapy treatment for cancer. The study focuses on delayed symptoms that begin more than 24 hours after chemotherapy and can last for several days.
Main inclusion criteria: Children between 6 months and 18 years old who have cancer and need chemotherapy that is likely to cause nausea and vomiting for at least 4 days are eligible. Patients must have a life expectancy of at least 3 months and be able to perform daily activities reasonably well. They must not have received anti-nausea medications within 48 hours before starting the study. Female patients who could become pregnant must have a negative pregnancy test. The chemotherapy schedule should include two similar treatment courses. Kidney and liver function tests must be within acceptable ranges.
Main exclusion criteria: Patients who are not experiencing delayed nausea and vomiting from chemotherapy cannot participate. Children who are receiving chemotherapy that does not typically cause nausea and vomiting, or those who cannot follow the study procedures, are not eligible. Patients with medical conditions that doctors believe would make participation unsafe are also excluded.
Study focus: The trial aims to determine if using fosaprepitant and aprepitant for a longer period can more effectively prevent nausea and vomiting in the days following chemotherapy compared to the current standard treatment duration of three days. The study uses a unique design where each child receives both the medication and a placebo during different chemotherapy cycles, allowing direct comparison. During one cycle, children receive a 3-day course of aprepitant capsules followed by placebo. During another cycle, they receive fosaprepitant intravenously for the entire chemotherapy period. The study will last up to 8 days during each chemotherapy cycle.
Investigational drug: Fosaprepitant is given intravenously to prevent nausea and vomiting caused by chemotherapy. It works by blocking specific receptors in the brain called neurokinin-1 (NK1) receptors that trigger these symptoms. The trial is testing whether using it throughout the entire chemotherapy course, rather than just the first three days, provides better protection for children.
Study on Aprepitant for Preventing Nausea and Vomiting After Bariatric Surgery in Patients
This trial is examining whether the medication aprepitant can reduce nausea and vomiting that commonly occurs after weight-loss surgery. These symptoms can cause significant discomfort and delay recovery after surgery.
Main inclusion criteria: Adults aged 18 years or older who are scheduled for weight-loss surgery such as laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis mini gastric bypass can participate. Patients must have a body mass index (BMI) over 30, indicating obesity. They must also have at least 2 risk factors for developing nausea and vomiting after surgery, which include being female, not smoking, needing opioid pain medications after surgery, having experienced these symptoms with previous surgeries, or having a surgery lasting longer than 1 hour.
Main exclusion criteria: People who do not experience nausea and vomiting after surgery cannot participate. Those outside the specified age range or who belong to certain vulnerable groups with specific health conditions or disabilities may not be eligible.
Study focus: The trial will evaluate how well aprepitant prevents nausea and vomiting after weight-loss surgery compared to a placebo. Researchers will monitor how often these symptoms occur and how severe they are using measurement scales. They will also track whether patients need additional medications to manage symptoms, how long patients stay in the recovery room and hospital overall, and how satisfied patients are with their recovery experience. Patients receive 125 mg of aprepitant before surgery and 80 mg after surgery.
Investigational drug: Aprepitant is given as capsules by mouth to prevent nausea and vomiting after surgery. Like fosaprepitant, it works by blocking neurokinin-1 (NK1) receptors in the brain that trigger these symptoms, helping patients feel more comfortable during their recovery.
Summary
The two ongoing clinical trials focus on preventing nausea and vomiting in two distinct patient groups: children undergoing cancer chemotherapy and adults having weight-loss surgery. Both studies investigate medications from the same family of drugs that work by blocking signals in the brain that cause these symptoms.
The trials are geographically distributed, with one taking place in the Netherlands and the other in Estonia. Each study addresses a specific medical situation where nausea and vomiting are common problems that can significantly affect patient comfort and recovery. The chemotherapy trial is particularly innovative in its approach, testing whether extending medication use beyond the standard three days provides better symptom control for children. The bariatric surgery trial focuses on preventing symptoms from occurring in the first place in patients who have multiple risk factors.
Both aprepitant and fosaprepitant work through the same mechanism of blocking neurokinin-1 receptors, representing a targeted approach to preventing these distressing symptoms in vulnerable patient populations.