Comparison of Delta-8-THC to Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy

Condition(s) targeted: Cancer

Intervention: inhaled delta-8-THC (Drug)

Phase: Phase 2

Status: Suspended

Sponsored by: Rafa Laboratories

Official(s) and/or principal investigator(s):
Nathan Cherny, MD, Principal Investigator, Affiliation: Shaare Zedek Medical Center, Dept. of Oncology

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.

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 design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome: VAS scale for nausea

Secondary outcome:

No. of emesis

VAS scale for delayed nausea

VAS scale for pain

VAS scale for appetite stimulation

VAS scale for dizziness

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

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

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

Shaare Zedek Medical Center, Jerusalem, Israel

Chaim Sheba Medical Center, Tel Hashomer, Israel

Starting date: November 2005
Ending date: November 2005
Last updated: February 27, 2007