Chemotherapy induced nausea and vomiting (CINV) is a major adverse effect of chemotherapy. This study is determining the incidence of vomiting/retching of the standard induction chemotherapy regimen for patients with acute myeloid leukemia (AML) who are also receiving an antiemetic known as aprepitant. The standard frontline chemotherapy for patients with AML consists of cytarabine given as a 7 day continuous infusion plus 3 days of an anthracycline, most commonly daunorubicin, on days 1-3. This is known as the 3+7 regimen. Antiemetic treatments are usually given to patients for nausea and vomiting. Granisetron (a 5-HT3 receptor antagonist) is used on the 3 daunorubicin days and other antiemetics can be used for breakthrough nausea/vomiting. This study will test that the prophylactic use of aprepitant, in addition to the standard antiemetic regimen used at Princess Margaret Hospital (PMH), will reduce the incidence of delayed onset vomiting/retching by Day 5 in AML patients receiving the standard 3+7 regimen, compared to retrospective data using this regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
41
Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
Princess Margaret Hospital
Toronto, Ontario, Canada
Percentage of Participants With Incidence of Vomiting/Retching From Day 1 Through End of Day 5
Cumulative incidence will be determined by the patient self-assessment form, supplemented by the nursing inpatient records.
Time frame: Day 1 through end of Day 5
Presence of Nausea Per Day, on Days 1-8.
Time frame: Days 1 to 8
Daily Number of Vomiting or Retching Incidents From Days 1-8
This will be determined by both self-assessment form which will be filled out by the patient on a daily basis, and review of the nursing inpatient records.
Time frame: Days 1 to 8
Percentage of Participants Experiencing Vomiting or Retching From Days 1-8.
This will be determined by both self-assessment form which will be filled out by the patient on a daily basis, and review of the nursing inpatient records.
Time frame: Days 1 to 8
Percentage of Patients Experiencing Nausea From Days 1-8.
Time frame: Days 1 to 8
Percentage of Patients' Use of Supplemental Anti-emetics as Determined by the Total Number of Doses Per Day and in Total, From Days 1-8.
Time frame: Days 1 to 8
To Evaluate the Tolerance of Aprepitant by Documenting All Toxicities on Days 1-8 and All Unexpected Serious Adverse Events up to Day 30.
Time frame: Days 1 to 8
Severity of Nausea Per Day, on Days 1-8.
Time frame: Days 1 to 8
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