Chemotherapy Induced Nausea and Vomiting
Conditions
Keywords
palonosetron, aprepitant, CINV, AML, multiple-days
Brief summary
The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.
Detailed description
This is an open-label, randomized, comparative, multicenter phase II study in patients with AML scheduled to receive multiple days chemotherapy. Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a computer-generated, random allocation schedule. Below are described the details for both antiemetic regimens: PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1 hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment. PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.
Interventions
DRUGPalonosetron + Aprepitant
Aloxi 0.25mg Emend 125/80/80 mg
DRUGPalonosetron
Aloxi 0.25mg
Sponsors
Associazione Salentina Angela Serra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response | 5 days after chemotherapy | The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emesis-free | 5 days after chemotherapy | Percentage of patients without emetic episodes |
| Presence of nausea | 5 days after chemotherapy | Presence of nausea graded according to Likert scale (none, mild, moderate and severe) |
| Complete Control | 5 days after chemotherapy | No emetic episode, no need for rescue medication, with a maximum grade of mild nausea |
| Patient global satisfaction | 5 days after chemotherapy | Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS) |
| Safety and tolerability | 5 days after chemotherapy | Number of patients experienced at least one adverse events related to study drug administration. |
| Treatment failure | 5 days after chemotherapy | Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first) |
Countries
Italy
Contacts
Primary ContactNicola Di Renzo, MD
Backup ContactClaudia Quintavalle, BsC
Outcome results
None listed