Status:
TERMINATED
Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy
Lead Sponsor:
Rafa Laboratories
Collaborating Sponsors:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
The study is comparing the use of inhaled delata-8-THC in the prevention of nausea and vomitting in patients being treated with moderately emetogenic chemotherapy, and the patients will continue use f...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00285051
Start Date
November 1 2005
End Date
February 1 2009
Last Update
December 23 2020
Active Locations (2)
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1
Shaare Zedek Medical Center
Jerusalem, Israel
2
Chaim Sheba Medical Center
Tel Litwinsky, Israel