Clinical trial NCT00285051: Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer
Keywords: emesis, nausea,
Lead sponsor: Rafa Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2006-02-01
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Group 1 cycle 1 - Ondansetron; cycle 2 - 300 mcg of delta-8-THC per dose Group 2 cycle 1 - Ondansetron; cycle 2 - 600 mcg of delta-8-THC per dose Group 3 cycle 1 - 300 mcg of delta-8-THC per dose cycle 2 - Ondansetron Group 4 cycle 1 - 600 mcg of delta-8-THC per dose cycle 2 - Ondansetron
Primary purpose: TREATMENT

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 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.

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 for 3 days afterward. Patients will be given rescue medication and will fill out VAS scales for nausea, pain, appetite and dizziness. Patients will be treated for 2 cycles, one cycle receiving active drug (one of 2 doses) and the other placebo. Patients receiving placebo will receive ondansetron injection before chemo and patients receiving active drug will receive a normal saline injection. Patients will take the drug 4 times daily for 3 days. The patients will return to clinic for a visit after 24-48 hours and 4 days. Patients will bring a urine sample to measure metabolite. Patients will be given a diary to monitor dosing and side effects as well as concomitant medication. The study will be conducted in 2 - 3 centers. There will be 108 patients enrolled with 27 in each of 4 groups:

Group 1 cycle 1 - Placebo cycle 2 - 300 mcg of delta-8-THC per dose Group 2 cycle 1 - Placebo cycle 2 - 600 mcg of delta-8-THC per dose Group 3 cycle 1 - 300 mcg of delta-8-THC per doseGroup cycle 2 - Placebo Group 4 cycle 1 - 600 mcg of delta-8-THC per dose cycle 2 - placebo

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

Primary outcomes:
measure: VAS scale for nausea
timeFrame: Up to 4 days after the patient receives chemotherapy. Measurements taken just before and 2 hours after inhalation morning and evening doses.
Secondary outcomes:
measure: No. of emesis
timeFrame: up to the 4 days after patient receives chemotherapy
measure: VAS scale for delayed nausea
timeFrame: 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.
measure: VAS scale for pain
timeFrame: 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
measure: VAS scale for appetite stimulation
timeFrame: Up to 4 days after patient receives chemotherapy. Measurements are taken just before and 2 hours after taking inhalation morning and evening doses
measure: VAS scale for dizziness
timeFrame: before and 2 hours after taking inhalation, morning and evening doses.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Tel Hashomer
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Dept. of Oncology
name: Nathan Cherny, MD
role: PRINCIPAL_INVESTIGATOR
References: