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

Rafa Laboratories

Status and phase: Terminated; Phase 2

Conditions: Cancer

Treatments: Drug: inhaled delta-8-THC 300mcg or 600mcg per dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT00285051

Rafa protocol THC002/NVP

Details and patient eligibility

About

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.

Full 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

Enrollment: 6 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

6 participants in 4 patient groups

Group 1

Experimental group

Description:

Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 300 mcg of delta-8-THC per dose

Treatment:

Drug: inhaled delta-8-THC 300mcg or 600mcg per dose

Group 2

Experimental group

Description:

Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 600 mcg of delta-8-THC per dose

Treatment:

Drug: inhaled delta-8-THC 300mcg or 600mcg per dose

Group 3

Experimental group

Description:

Chemo cycle 1 - 300 mcg of delta-8-THC per dose, Chemo cycle 2 - IV Ondansetron

Treatment:

Drug: inhaled delta-8-THC 300mcg or 600mcg per dose

Group 4

Experimental group

Description:

Chemo cycle 1 - 600 mcg of delta-8-THC per dose Chemo cycle 2 - IV Ondansetron

Treatment:

Drug: inhaled delta-8-THC 300mcg or 600mcg per dose