Clinical trial · Interventional
Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy
Study to Compare the Safety and Efficacy of 2 Different Doses of Inhaled D8-THC to Standard Therapy With Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study drug expiry date not extended
Summary
Brief summary (as posted)
Patients will be treated for 2 consecutive chemo cycles with the study drug for one and placebo for the other. In addition, patients will receive an injection before the chemo, either ondansetron (if receiving placebo inhalation) or normal saline) if receiving active study drug. They will take study medication for 3 days, 4 times daily and fill out VAS scores before and after doses. Patients will be given rescue medication with each dose.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| inhaled delta-8-THC 300mcg or 600mcg per dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 300 mcg of delta-8-THC per dose
- interventionNames
- Drug: inhaled delta-8-THC 300mcg or 600mcg per dose
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 600 mcg of delta-8-THC per dose
- interventionNames
- Drug: inhaled delta-8-THC 300mcg or 600mcg per dose
- type
- EXPERIMENTAL
- label
- Group 3
- description
- Chemo cycle 1 - 300 mcg of delta-8-THC per dose, Chemo cycle 2 - IV Ondansetron
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion criteria: * Signed informed consent * Man or woman between 18 and 85 years of age * Patients who will be receiving at least 2 more cycles of moderately emetogenic chemotherapy * Patients who are cognitively intact * Performance Status of 60% or greater on the Karnofsky Scale * Negative pregnancy test at screening visit in females of childbearing potential * Use of appropriate contraceptive methods for females of childbearing potential during treatment (e.g. hormonal contraception, intrauterine device \[IUD\]) Exclusion Criteria: * A history of psychiatric illness. * A history of asthma and any other chronic respiratory illness. * Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study. * Serious illnesses such as asthma, diabetes mellitus, active peptic ulcer disease, infection, cardiovascular disease or any other disease which may affect the oucome parameters of this study * Abnormal liver function tests (ALT, AST or AP \> 2.5 x upper normal limit) * Abnormal renal function (e.g. serum creatinine \> 2 x upper normal limit) * Abnormal pulmonary function test which in the judgment of the investigator is incompatible with inhalation of the study drug * Known intolerance/hypersensitivity to study drugs (THC, ondansetron or dexamethasone) or drugs of similar chemical structure or pharmacological profile * History of addiction to alcohol or drugs * Existing or intended pregnancy or lactation * Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
References
Publications (0)
Data not yet available