Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy
Cancer
About this trial
This is an interventional treatment trial for Cancer focused on measuring emesis, nausea,
Eligibility Criteria
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
Sites / Locations
- Shaare Zedek Medical Center
- Chaim Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Group 1
Group 2
Group 3
Group 4
Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 300 mcg of delta-8-THC per dose
Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 600 mcg of delta-8-THC per dose
Chemo cycle 1 - 300 mcg of delta-8-THC per dose, Chemo cycle 2 - IV Ondansetron
Chemo cycle 1 - 600 mcg of delta-8-THC per dose Chemo cycle 2 - IV Ondansetron