Clinical trial · Interventional
Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/Dexamethasone With or Without Dronabinol for the Prevention of Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if adding dronabinol in combination with the standard of care (dexamethasone and palonosetron) can better help to control nausea and vomiting in patients receiving chemotherapy. The safety of the drug combinations will also be studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Nausea and Vomiting | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| dronabinol | Drug | — | UNRESOLVED |
| palonosetron hydrochloride | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I: Palonosetron, Dexamethasone + Dronabinol
- description
- Palonosetron hydrochloride intravenous (IV) and dexamethasone IV 30 minutes before chemotherapy administration on day 1, and oral dronabinol 3 times a day for 5 days beginning 30 minutes before chemotherapy administration on day 1.
- interventionNames
- Drug: dexamethasone
- Drug: dronabinol
- Drug: palonosetron hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- Arm II: Palonosetron + Dexamethasone
- description
- Palonosetron hydrochloride and dexamethasone as in arm I, and oral placebo 3 times a day for 5 days beginning 30 minutes before chemotherapy on day 1.
- interventionNames
- Drug: dexamethasone
- Drug: palonosetron hydrochloride
- Other: placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically documented solid tumor 2. Receiving moderately emetogenic chemotherapy for the first time: Patients may be chemotherapy naive, or patients may have previously received a mildly emetogenic agent (such as a taxane) if no nausea/vomiting was experienced with that chemotherapy 3. Scheduled to receive cyclophosphamide \</= 1500 mg/m\^2 IV and/or doxorubicin \>/= 40 mg/m\^2 IV given as single doses on Day 1. Patients on combination regimens with these agents are eligible 4. Age \>/= 18 years 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 6. Adequate organ reserve as follows: 1) Hematologic - white blood cell count (WBC) \>/= 3000/microL, AGC \>/= 1500/microL, platelet \>/= 100,000/microL; 2) Renal - Creatinine \</= 1.5 times upper limit of normal; 3) Hepatic - Bilirubin and transaminases \</= 2.5 times upper limit of normal 7. The effects of the three-drug regimen on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 8. Negative qualitative B-human chorionic gonadotropin (HCG) (pregnancy test) 9. Signed informed consent Exclusion Criteria: 1. Scheduled to receive highly emetogenic chemotherapy (Hesketh Level 5 - such as cisplatin, streptozotocin, dacarbazine, carmustine, hexamethylmelamine, mechlorethamine, procarbazine) during the study period 2. Scheduled to receive moderately emetogenic chemotherapy (Hesketh Level 3-4) after Day 1 of the study period 3. Experienced nausea and/or vomiting with prior administration of chemotherapy 4. Prior moderately or highly emetogenic chemotherapy: Patients may have previously received a mildly emetogenic agent (such as a taxane) if no nausea/vomiting was experienced with that chemotherapy 5. Scheduled to receive cranial, abdominal, or pelvic radiation therapy during the study period 6. Treatment with any investigational agent within 30 days of randomization 7. Scheduled to receive treatment during the study period with other potential or known antiemetic agents. Chronically used benzodiazepines may be continued as a single nightly dose for sleep. 8. Scheduled to receive corticosteroid treatment other than the study drug dose during the study period 9. Uncontrolled primary or metastatic CNS tumor (including those with uncontrolled seizures) 10. Other physical causes for nausea or vomiting (such as bowel obstruction) not related to chemotherapy administration 11. Recent history of unexplained nausea or vomiting or history of frequent nausea or vomiting 12. Active bacterial or fungal infection for which administration of a corticosteroid would be contraindicated 13. Hypersensitivity to any of the study agents 14. Sensitivity to sesame oil 15. Planned simultaneous administration of any other investigational agents 16. Pregnant or nursing women 17. Previous poor tolerance of cannabinoids 18. Habitual cannabinoid use or unwillingness to avoid the use of marijuana during the study period 19. Previous use of dronabinol or nabilone
References
Publications (0)
Data not yet available