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Study on Palonosetron and Netupitant for Preventing Nausea in Endometrial Cancer Patients Undergoing Taxane-Platinum 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 effectiveness of a treatment for endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The treatment being tested is called Akynzeo, which is a combination of two active substances, palonosetron and netupitant. These substances are used to prevent nausea and vomiting, which are common side effects of chemotherapy. The study will also involve the use of chemotherapy drugs paclitaxel and carboplatin, and may include additional treatments with immunotherapy, which helps the immune system fight cancer.

The purpose of this study is to evaluate how well a single oral dose of Akynzeo works in preventing nausea and vomiting in patients who are receiving chemotherapy for the first time. Participants will receive the treatment during their first cycle of chemotherapy, and the study will monitor their response over a period of 120 hours. Some participants may receive a placebo instead of Akynzeo to compare the effectiveness of the treatment. The study will also assess the safety and tolerability of Akynzeo by monitoring any side effects experienced by the participants.

Throughout the study, participants will be closely observed to see if they achieve a complete response, which means no vomiting and no need for additional medication to control nausea. The study will also look at how well the treatment works during different phases of the chemotherapy cycle, such as the acute phase (first 24 hours) and the delayed phase (24 to 120 hours). The overall goal is to determine if Akynzeo can effectively manage nausea and vomiting in patients with endometrial cancer undergoing chemotherapy, with or without the addition of immunotherapy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing written consent and confirming eligibility, including a diagnosis of endometrial cancer and being new to chemotherapy.
Step 2
Initial treatment phase
Receive a single oral dose of Akynzeo (palonosetron, netupitant) in capsule form to prevent nausea and vomiting.
This medication is taken before starting chemotherapy.
Step 3
Chemotherapy administration
Undergo chemotherapy with Paclitaxel and Carboplatin, administered as infusions.
Additional medications may include Atezolizumab or Pembrolizumab (immunotherapy) and Dexamethasone (to reduce inflammation).
Step 4
Monitoring phase
Observation for any side effects or adverse reactions to the treatment.
Regular assessments to evaluate the effectiveness of the antiemetic treatment and overall response to chemotherapy.
Step 5
Follow-up and evaluation
Complete response is measured by the absence of vomiting and the need for additional medication to control nausea.
The study aims to assess the effectiveness of the treatment over a period of 0 to 120 hours after chemotherapy begins.

Who can join the trial?

5 criteria

The patient must be at least 18 years old, able to understand the study procedures, and agree to participate by signing a written consent form.
The patient must have a confirmed diagnosis of endometrial cancer, which is cancer that starts in the lining of the uterus.
The patient must have an ECOG performance status of 0, 1, or 2. This is a scale used to assess how a patient's disease is affecting their daily living abilities, with 0 being fully active and 2 indicating some limitations but still able to care for themselves.
The patient must have adequate organ function, meaning their organs are working well enough to receive a combination of taxane-platinum therapy (a type of chemotherapy) with or without additional treatment called immunotherapy, based on the doctor's judgment.
The patient must be naive to chemotherapy, which means they have not received chemotherapy treatment before.

Who cannot join the trial?

10 criteria

Patients who have already received chemotherapy for their cancer.
Patients who are not female, as the study is only for women.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are taking medications that could affect the study results.
Patients who are unable to follow the study procedures or instructions.
Patients who have allergies or reactions to the study medication or similar drugs.
Patients who are pregnant or breastfeeding, as the study is not safe for them.
Patients who have participated in another clinical trial recently.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Ordine Mauriziano Di Torino
Responsive
Turin, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

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Investigated drugs

Akynzeo
is a medication used to prevent nausea and vomiting caused by chemotherapy. It combines two active ingredients that work together to block the signals in the brain that trigger these symptoms. In this trial, Akynzeo is being tested for its effectiveness in preventing nausea and vomiting in patients with endometrial cancer who are receiving chemotherapy.
Paclitaxel
is a chemotherapy drug used to treat various types of cancer, including endometrial cancer. It works by stopping the growth of cancer cells and is often used in combination with other chemotherapy drugs to enhance its effectiveness.
Carboplatin
is another chemotherapy medication used to treat cancer. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, carboplatin is used in combination with paclitaxel to treat patients with endometrial cancer.
Immunotherapy
is a type of cancer treatment that helps the immune system fight cancer. It can be used alongside chemotherapy to improve the body's natural defenses against cancer cells. In this trial, some patients may receive immunotherapy in addition to chemotherapy to evaluate its potential benefits.

What is already known about the treatment

Akynzeo – Akynzeo is administered orally and is used to prevent nausea and vomiting in patients undergoing chemotherapy, specifically those with endometrial cancer receiving a combination of taxane and platinum-based chemotherapy. It is currently recognized in medical literature as an effective antiemetic treatment. The main therapeutic indication for Akynzeo is to prevent chemotherapy-induced nausea and vomiting. At the molecular level, it works by blocking the action of substances in the brain that trigger nausea and vomiting, combining a neurokinin-1 (NK1) receptor antagonist and a serotonin-3 (5-HT3) receptor antagonist. It is classified pharmacologically as an antiemetic medication.

Investigated diseases

Endometrial cancer – This is a type of cancer that begins in the lining of the uterus, known as the endometrium. It is most commonly diagnosed in women who have gone through menopause. The disease often presents with symptoms such as abnormal vaginal bleeding or discharge, which can prompt early detection. As the cancer progresses, it may invade the muscular layer of the uterus and potentially spread to other parts of the body. The progression can vary, with some cases remaining localized while others may metastasize to distant organs. Early detection and monitoring are crucial for managing the disease effectively.