Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer (NCT06726291) | Clinical Trial Compass
RecruitingPhase 4
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer
Italy84 participantsStarted 2024-02-26
Plain-language summary
The clinical trial concerns the use of an innovative \"anti-emetic\" drug (that is, anti-vomiting and nausea) in subjects affected by endometrial cancer. It is addressed to patients who have never received chemotherapy before and are about to start a treatment with platinum and taxanes with or without immunotherapy for endometrial cancer.
The primary objective of the study is to learn if the drug is able to avoid the occurrence of vomiting and post- nausea chemotherapy within 120 hours after cycle 1 with carboplatin and paclitaxel with or without immunotherapy.
Partecipants will take the drug before the chemotherapy/immunotherapy (single dose at day one of each cycle of therapy, that is one capsule before treatment). The entire duration of participation in the study may extend to the fourth cycle of chemotherapy/immunotherapy.
Patients will fill in questionnaires and keep a diary of the number and intensity of symptoms (vomiting and nausea).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject is at least 18 years of age, able to understand the study procedures, and agrees to participate in the study by providing written informed consent
* Subject has histologically or cytologically proven endometrial cancer
* Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Adequate organ function allowing the patient to receive taxane-platinum combination therapy with or without immunotherapy according to clinical practice and opinion of treating physician
* Naive to chemotherapy
* Women of child-bearing potential must have a negative pregnancy test (urine). Female patients are considered of child-bearing potential following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Patients are considered to not be of child-bearing potential if they have a history of tubal ligation or hysterectomy or are post-menopausal with a minimum of 1 year without menses. Patients of child-bearing potential must agree to adequate birth control if conception is possible during the study and for 6 months after the last dose; in this case, patients must take a monthly pregnancy test for the duration of the study
Exclusion Criteria:
* They will experience emesis within the 24 hours before receipt of 1 course of chemotherapy
* will be scheduled to radiation therapy to the abdomen or pel…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness
Timeframe: overall phase (0-120 hours after NEPA administration) at cycle 1
Trial details
NCT IDNCT06726291
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano