Using Akynzeo to prevent nausea in endometrial cancer patients undergoing chemotherapy
Akynzeo as Antiemetic Treatment in Patients With Endometrial Cancer Treated With Taxane- Platinum Combination Chemotherapy. NOEME Study.
This study is testing if a new combination of anti-nausea medication can help women with endometrial cancer avoid nausea and vomiting during their first round of chemotherapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 8 sites (Brescia, BS and 7 other locations) |
| Trial ID | NCT06726291 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combination antiemetic drug, netupitant and palonsetron, in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with endometrial cancer who are starting their first chemotherapy regimen. Participants will take a single dose of the drug before each chemotherapy cycle and will monitor their symptoms through questionnaires and diaries. The study aims to assess the drug's ability to reduce the occurrence of vomiting and nausea within 120 hours after the first cycle of treatment. It is a phase IV, multicentric, single-arm study focusing on chemo-naive patients receiving a taxane-platinum combination with or without immunotherapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a confirmed diagnosis of endometrial cancer who have never received chemotherapy.
Not a fit: Patients who have previously undergone chemotherapy or those with severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients by reducing the debilitating side effects of chemotherapy.
How similar studies have performed: Other studies have shown success with similar antiemetic approaches, indicating a promising avenue for managing chemotherapy side effects.
Eligibility criteria
Show full inclusion / exclusion criteria
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 pelvis within 1 week before day 1 or between day 1 and 5 * Will be scheduled to undergo bone marrow or stem-cell transplant * Chronic systemic corticosteroid use * Brain metastasis * Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder * History or predisposition to cardiac conduction abnormalities, torsade des pointes or severe cardiovascular diseases * Subject is pregnant or breastfeeding or is expecting to conceive children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study treatment * They have any known hypersensitivity or contraindication to the components of the study drugs (hypersensitivity to the active substance or to any of the excipients contained in the product, as listed in the relevant section of the summary of product characteristics)
Where this trial is running
Brescia, BS and 7 other locations
- ASST Spedali Civili di Brescia — Brescia, Bs, Italy (Not_yet_recruiting)
- ASST Lecco - A. Manzoni Hospital — Lecco, Lc, Italy (Recruiting)
- Istituto Oncologico Veneto — Padova, Pd, Italy (Recruiting)
- Centro di Riferimento Oncologico (CRO) IRCCS — Aviano, Pn, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Ordine Mauriziano di Torino — Torino, To, Italy (Active_not_recruiting)
- AOU Città della Salute e della Scienza di Torino — Torino, To, Italy (Not_yet_recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
- Istituto Europeo di Oncologia — Milan, Italy (Active_not_recruiting)
Study contacts
- Principal investigator: Monika Ducceschi, MD — Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Study coordinator: Monika Ducceschi, MD
- Email: monika.ducceschi@istitutotumori.mi.it
- Phone: +39 02 2390 2342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.