Cancer Clinical Trial
Official title:
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
Verified date | April 2017 |
Source | Rafa Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Shaare Zedek Medical Center | Jerusalem | |
Israel | Chaim Sheba Medical Center | Tel Hashomer |
Lead Sponsor | Collaborator |
---|---|
Rafa Laboratories | Teva Branded Pharmaceutical Products R&D, Inc. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS scale for nausea | subjective measurement of feeling of nausea. Patients to indicate on a horizontal line, how much nausea the patient feels, lower score = less nausea, higher score is more severe. Measurement is made on the line from "none" to "severe" for score. | Up to 4 days after the patient receives chemotherapy. Measurements taken just before and 2 hours after inhalation morning and evening doses. | |
Secondary | No. of emesis | number of times patient vomits recorded daily after receiving cancer chemotherapy | up to the 4 days after patient receives chemotherapy | |
Secondary | VAS scale for delayed nausea | Subjective measurement of feeling of nausea. Patients to indicate on a horizontal line, lower score = less nausea, higher score is more severe. Measurement is made on the line from "none" to "severe" for score. | Up to the 4 days after patient receives chemotherapy. Measurements taken just before and 2 hours after taking inhalation morning and evening doses. Delayed nausea is nausea that occurs 24 hours or more after receiving cancer chemotherapy. | |
Secondary | VAS scale for pain | subjective measurement of feeling of pain at the moment Patients to indicate on a horizontal line, lower score = less pain, higher score is more severe pain. Measurement is made on the line from "none" to "severe" for score. | Up to the 4 days after the patient takes the study medication after receiving chemotherapy. Measurements taken just before and 2 hours after inhalation morning and evening doses | |
Secondary | VAS scale for appetite stimulation | Patients to indicate on a horizontal line, lower score = less appetite, higher score is more appetite. Measurement is made on the line from "not at all" to "very hungry" for score. | Up to 4 days after patient receives chemotherapy. Measurements are taken just before and 2 hours after taking inhalation morning and evening doses | |
Secondary | VAS scale for dizziness | subjective measurement of feeling dizzy Patients to indicate on a horizontal line, lower score = less nausea, higher score is more severe. Measurement is made on the line from "none" to "severe" for score. | before and 2 hours after taking inhalation, morning and evening doses. |
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