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About
RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive chemotherapy in combination with a pre-defined standard 5-Hydroxytryptamine-3 (5-HT3) antagonist or corticosteroid regimen with or without a benzodiazepine on day 1. If breakthrough nausea or vomiting occurs, patients then receive fosaprepitant dimeglumine IV once per standard administration guidelines. Patients with treatment response may receive additional doses of oral aprepitant once on days 2 and 3. Patients with persistent nausea/vomiting after 2 hours and who desire further treatment may receive standard rescue therapy with prochlorperazine, metoclopramide, or haloperidol with or without additional lorazepam until relief, at the discretion of the provider.
Patients complete a diary at baseline, and then at 2, 12, and 24 hours that includes a Visual Analogue Scale (VAS) for nausea; VAS for sedation; and questions about emesis and retching frequency, headache, dizziness, somnolence, and ability to take food and liquids orally. Patients also complete the Functional Living Index-Emesis Quality of Life survey at baseline and at 24 hours.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of cancer
Scheduled to receive inpatient chemotherapy containing at least moderately emetogenic agents
Scheduled to receive 5-HT3 receptor antagonist antiemetic (e.g., ondansetron, granisetron, palonosetron, dolasetron mesylate, or dexamethasone with or without a benzodiazepine) on the day of chemotherapy
Self-report of at least mild nausea (for which the patient feels needs rescuing) or moderate nausea (a score of ≥ 2 on a 4-point Likert scale) OR has had ≥ 1 episode of emesis since receiving chemotherapy
No history of chronic nausea and/or vomiting (without chemotherapy), anticipatory nausea and/or vomiting, or emesis within 24 hours before chemotherapy
No symptomatic brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
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34 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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