Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients
Chemotherapy Induced Nausea and Vomiting
About this trial
This is an interventional supportive care trial for Chemotherapy Induced Nausea and Vomiting focused on measuring palonosetron, aprepitant, CINV, AML, multiple-days
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS
- Patient eligible for AML-like induction therapy
- Candidate for multiple-days chemotherapy (minimum 3 days)
- Age more, equal18 years
- ECOG 0-2
- Not pregnant or nursing
- Must be able to complete the patient's diary
- Provide written informed consent
Exclusion Criteria:
- AML or HR-MDS therapy-related
- Active infection requiring intravenous antibiotics
- Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for more/equal 5 years
- Unacceptable hepatic function (more of 2 times the upper limit of normal for liver transaminases) and renal function (creatinine more of 1.5 times the upper limit of normal) unless disease-related
- Myocardial infarction within the past 6 months
- Psychiatric or CNS disorders interfering with ability to comply with study protocol
- Known hypersensitivity to 5-HT3 antagonists and their components CSF involvement
- Pre-existing nausea or vomiting
Sites / Locations
- Università-Azienda Policlinico di Bari
- Ospedale PerrinoRecruiting
- Ospedale Pugliese-Ciacco
- IRCCS Casa Sollievo della SofferenzaRecruiting
- Ospedale Vito FazziRecruiting
- Ospedale "Cardinale Panico"Recruiting
- A.O. Riuniti Papardo - PiemonteRecruiting
- Casa di Cura "La Maddalena"Recruiting
- Ospedale Ascoli Civico PalermoRecruiting
- Ospedale MoscatiRecruiting
- ARON " Cardarelli"Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Palonosetron + Aprepitant
Palonosetron
Oral aprepitant will be given on days 1-3 (day 1, 125 mg 1 h before chemohterapy; days 2-3, 80 mg) multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.
multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.