A Phase 2 interventional study of Netupitant/Palonosetron in Chemotherapy-induced Nausea and Vomiting, sponsored by Consorzio Oncotech. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Consorzio Oncotech · Phase 2, Interventional, and Prevention
This study evaluates if the activity of one-day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles).
Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles:
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's enrollment of 150 is above the median of 115 across 703 interventional studies indexed under Nausea.
Browse Nausea studies →Consorzio Oncotech is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Netupitant/Palonosetron (NEPA) will be administered orally at the dose of 300 MG (milligrams) netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle. * Dexamethasone 12 mg will be added on day 1 only of each cycle.
Drug: Netupitant/Palonosetron
Also known as: Netupitant/Palonosetron 300 MG-0.5 MG Oral Capsule [AKYNZEO]
Complete response
The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase of all AC-based chemotherapy cycles
Time frame: During the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles (each cycle is 21 days)
Acute and Delayed Phase Complete Response
Rate of complete control (defined as no emetic episode and no need for rescue medication)
Time frame: During the Acute Phase [0-24 hours after chemotherapy (CT)] and the Delayed (25-120 hours) phase
Complete Control
Rate of complete control (defined as complete response with a maximum grade of mild nausea)
Time frame: During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles (each cycle is 21 days), up to 4 cycles
Emesis-Free
Percentage of emesis-free patients (no emetic episodes) after any AC-based chemotherapy administration.
Time frame: During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days)and separately on single days of all CT cycles,up to 4 cycles.Also during the period between two consecutive cycles
Nausea
Presence of nausea graded according to Likert scale (none, mild, moderate and severe)
Time frame: During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (of 21 days)and separately on single days of all chemotherapy cycles, up to 4 cycles.Also during the period between two consecutive cycles
Global satisfaction with antiemetic therapy: Visual Analogue Scale (VAS)
Patient global satisfaction with antiemetic therapy, as measured by a Visual Analogue Scale (VAS). Scale ranges are 0-10 (0 represents maximum dissatisfaction, 10 represents maximum satisfaction)
Time frame: During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles
Safety profile (according to CTCAE)
Safety profile according to CTCAE
Time frame: During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles
No study locations are listed for this record.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Consorzio Oncotech