Clinical trial · Interventional
Aprepitant or Ondansetron in Treating Nausea and Vomiting Caused By Opioids in Patients With Cancer
A Pilot Study of Aprepitant Versus Ondansetron for the Treatment of Opioid Induced Nausea and Vomiting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
RATIONALE: Antiemetic drugs, such as aprepitant and ondansetron, may help lessen nausea and vomiting caused by opioids. It is not yet known whether aprepitant is more effective than ondansetron in treating nausea and vomiting caused by opioids in patients with cancer. PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to ondansetron in treating nausea and vomiting caused by opioids in patients with cancer.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Nausea and Vomiting | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aprepitant | Drug | — | UNRESOLVED |
| ondansetron hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ARM A
- interventionNames
- Drug: aprepitant
- type
- EXPERIMENTAL
- label
- ARM B
- interventionNames
- Drug: ondansetron hydrochloride
Primary outcomes (1)
- measure
- Control of nausea and vomiting
- timeFrame
- Day 1 and Day 7
Secondary outcomes (4)
- measure
- Quality of life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * History of malignancy (including hematological malignancies) * Has pain requiring opioid analgesics * Nausea and vomiting (associated with opioid analgesic use) that is unrelieved by at least one standard antiemetic regimen (including 5HT3 antagonist and dexamethasone combination therapy) * Patients who have failed ondansetron hydrochloride for treatment of opioid-induced nausea and vomiting will be excluded from the study PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Able to assess severity of nausea and vomiting and document it in the diary * Women must not be pregnant or lactating * Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception * Urine pregnancy test will be given to women of childbearing age * No concerns about compliance with medication regimen or medical follow-up (patient must be able to tolerate oral dosing) * No severe or chronic illness or other causes of nausea and vomiting, that in judgment of the treating physician, will place patient at risk * No severe gastrointestinal obstruction or active peptic ulcer disease * Serum ALT and AST \< 2 times upper limit of normal (ULN) * Serum bilirubin \< 2 times ULN * Serum alkaline phosphatase \< 2 times ULN PRIOR CONCURRENT THERAPY: * No surgery within the past 7 days * No chemotherapy within the past 7 days * No total or lower body radiation therapy within the past 7 days * Patient may not be scheduled to undergo total body irradiation or lower body irradiation, chemotherapy, or surgery during study participation * Patient must not be taking warfarin
References
Publications (0)
Data not yet available