Ongoing Clinical Trials for Prophylaxis Of Nausea And Vomiting
This article provides an overview of 3 ongoing clinical trials focused on preventing nausea and vomiting in different patient populations. These studies are investigating various medication combinations and their effectiveness in preventing nausea and vomiting caused by chemotherapy or surgery. The trials are taking place across several European countries including Romania, Poland, Greece, Italy, Germany, and France.
Clinical trial locations
- France
- Germany
- Greece
- Italy
- Poland
- Romania
Study on IV NEPA (Fosnetupitant/Palonosetron) for Preventing Chemotherapy-Induced Nausea and Vomiting in Pediatric Cancer Patients
This trial is investigating IV NEPA, a combination of fosnetupitant and palonosetron, for preventing nausea and vomiting in children with cancer who are undergoing chemotherapy. The study is divided into two parts and will compare IV NEPA with other commonly used treatments.
Who can participate: Children from 3 months to under 18 years of age can join this study if they meet specific weight requirements. For Part I, Cohort 1, participants must be younger than 6 months and weigh at least 4 kg, or be 6 months or older and weigh at least 6 kg. For Part I, Cohort 2, participants must weigh at least 4 kg, and for Part II, participants must weigh at least 6 kg. The child must be scheduled to receive highly emetogenic chemotherapy, which is treatment that is very likely to cause nausea and vomiting. They should have a life expectancy of at least 3 months and, for those aged 10 years or older, have an ECOG Performance Status of 2 or less. Children with known liver or kidney problems may participate if their test results are within safe limits.
Who cannot participate: Children who are not within the age range of 3 months to less than 18 years, or those not receiving chemotherapy that causes nausea and vomiting cannot join. Participants with medical conditions that would make the study unsafe, those who are pregnant or breastfeeding, or those who have participated in another clinical trial within the last 30 days are excluded. Children with known allergies to the study medications or those unable to follow study procedures also cannot participate.
What the study focuses on: The trial aims to determine how well IV NEPA prevents nausea and vomiting during and after chemotherapy. In Part I, children receive either a single dose or repeated doses of IV NEPA, with monitoring for safety and effectiveness. Part II involves repeated cycles of IV NEPA compared to a combination of fosaprepitant and ondansetron. The study will assess both immediate and delayed nausea and vomiting that occurs more than 24 hours after chemotherapy begins.
Medications being tested: The main treatment is IV NEPA, which combines fosnetupitant and palonosetron. These medications work together to block the signals in the brain that trigger nausea and vomiting. The study also compares IV NEPA with fosaprepitant, ondansetron, and aprepitant, which are other medications used to prevent chemotherapy-induced nausea and vomiting.
Study on Palonosetron and Netupitant for Preventing Nausea in Endometrial Cancer Patients Undergoing Taxane-Platinum Chemotherapy
This trial is evaluating Akynzeo, a combination of palonosetron and netupitant, for preventing nausea and vomiting in women with endometrial cancer who are receiving chemotherapy for the first time.
Who can participate: Women aged 18 years or older with a confirmed diagnosis of endometrial cancer can join this study. Participants must have an ECOG performance status of 0, 1, or 2, which means they should be able to carry out most daily activities with some possible limitations. They must have adequate organ function to safely receive taxane-platinum chemotherapy with or without immunotherapy. Importantly, participants must be new to chemotherapy, meaning they have not received this type of treatment before.
Who cannot participate: Women who have already received chemotherapy for their cancer cannot join. The study is only for female patients. Those who are part of a vulnerable population requiring special protection, have other medical conditions that might interfere with the study, or are taking medications that could affect results are excluded. Women with allergies to the study medication, those who are pregnant or breastfeeding, or those unable to follow study procedures cannot participate. Recent participation in another clinical trial also excludes potential participants.
What the study focuses on: The trial aims to determine how well a single oral dose of Akynzeo prevents nausea and vomiting during the first cycle of chemotherapy. Participants are monitored over 120 hours to assess whether they achieve a complete response, meaning no vomiting and no need for additional anti-nausea medication. The study evaluates effectiveness during both the acute phase (first 24 hours) and delayed phase (24 to 120 hours) after chemotherapy begins.
Medications being tested: Akynzeo is the main medication being tested, combining two active ingredients that block the brain signals triggering nausea and vomiting. Participants will also receive paclitaxel and carboplatin chemotherapy. Some may receive additional immunotherapy with atezolizumab or pembrolizumab, along with dexamethasone to reduce inflammation.
Study on Amisulpride, Dexamethasone Phosphate, and Ondansetron for Preventing Post-Operative Nausea and Vomiting in Children
This trial is studying whether amisulpride can effectively prevent nausea and vomiting in children after surgery. The medication will be compared with other commonly used treatments.
Who can participate: Children from birth (in France, from one month of age) to 17 years old can join this study. Both male and female patients are eligible. A signed consent form from both the patient and their parents is required. Children must be scheduled for non-emergency surgery under general anesthesia expected to last at least 30 minutes, preferably eye surgery, removal of tonsils and adenoids, or ear surgery. Participants must have an ASA risk score of I-III, which assesses overall health before surgery. Female participants who can have children must use effective contraception from screening until at least 48 hours after receiving the study drug.
Who cannot participate: Children who are not within the specified age range or those who do not experience post-operative nausea and vomiting cannot participate. Those with medical conditions or taking medications that might interfere with the study are excluded. Children with allergies to the study medication or those unable to follow study instructions cannot join.
What the study focuses on: The trial aims to find the best way to prevent nausea and vomiting after surgery in children. Participants receive medications intravenously before surgery and are then observed for 24 hours afterward. The primary goal is achieving a complete response, defined as no vomiting or retching and no need for rescue anti-nausea medication during this period. Researchers will record the timing and severity of any symptoms, along with any side effects.
Medications being tested: Amisulpride is the main medication being studied, administered directly into a vein. It works by blocking dopamine receptors in the brain to reduce nausea and vomiting. The study also involves dexamethasone phosphate and ondansetron for comparison purposes.
Summary
These three clinical trials represent different approaches to preventing nausea and vomiting in various patient populations. Two trials focus on children: one studying chemotherapy-induced nausea and vomiting in pediatric cancer patients across Romania, Poland, and Greece, and another examining post-operative nausea and vomiting in children undergoing surgery in Germany and France. The third trial focuses on adult women with endometrial cancer in Italy.
A notable pattern is the focus on combination treatments. The pediatric cancer trial investigates IV NEPA, combining fosnetupitant and palonosetron, while the endometrial cancer trial evaluates Akynzeo, combining palonosetron and netupitant. These combinations aim to provide more effective prevention by blocking multiple pathways that trigger nausea and vomiting.
The trials demonstrate a concentration of research in European countries, particularly in pediatric populations, reflecting the medical community’s efforts to improve quality of life for patients undergoing challenging treatments. Each study is designed to compare new or optimized treatments with existing standard therapies, helping to establish more effective prevention strategies for this common and distressing side effect.
