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

NCT00285051 | Terminated Phase 2

• 1 other identifier: Rafa protocol THC002/NVP
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

emesis, nausea,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• No. of emesis

  up to the 4 days after patient receives chemotherapy

• VAS scale for delayed nausea

  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.

• VAS scale for pain

  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

• VAS scale for appetite stimulation

  Up to 4 days after patient receives chemotherapy. Measurements are taken just before and 2 hours after taking inhalation morning and evening doses

• VAS scale for dizziness

  before and 2 hours after taking inhalation, morning and evening doses.

Study Arms (4)

Group 1

EXPERIMENTAL

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

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

Group 2

EXPERIMENTAL

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

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

Group 3

EXPERIMENTAL

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

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

Group 4

EXPERIMENTAL

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

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

Interventions

inhaled delta-8-THC 300mcg or 600mcg per dose DRUG

drugs to be used to prevent/treat nausea and/or vomiting due to cancer chemotherapy drug Patients will receive chemotherapy on day 0 and receive study medication, return on day 1or 2 and again on day 4 to return medication. There will be at least 10 days between the last dose of study medication from the first cycle and the first dose for the 2nd cycle.. Patients will receive for each chemotherapy cycle either IV Ondansetron and Placebo inhalation, or IV Placebo and delta-8-THC inhalation. The patients will be randomized to receive one of 2 doses of the THC, either 300mcg or THC or 600mcg of THC

Also known as: IV Ondansetron (comparator)

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[IUD\])

You may not qualify if:

• 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

Sponsors & Collaborators

• Rafa Laboratories: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (2)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, Israel

Location

MeSH Terms

Conditions

Neoplasms; Vomiting; Nausea

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Nathan Cherny, MD

  Shaare Zedek Medical Center, Dept. of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 1, 2006
• Study Start: November 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 23, 2020

Record last verified: 2017-04

Locations

IL (2)