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

Primary Purpose

Cancer

Status
Terminated
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
inhaled delta-8-THC 300mcg or 600mcg per dose
Sponsored by
Rafa Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring emesis, nausea,

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shaare Zedek Medical Center
  • Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

No. of emesis
number of times patient vomits recorded daily after receiving cancer chemotherapy
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.
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.
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.
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.

Full Information

First Posted
January 31, 2006
Last Updated
December 20, 2020
Sponsor
Rafa Laboratories
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00285051
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Study drug expiry date not extended
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rafa Laboratories
Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
emesis, nausea,

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
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
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 300 mcg of delta-8-THC per dose
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 600 mcg of delta-8-THC per dose
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Chemo cycle 1 - 300 mcg of delta-8-THC per dose, Chemo cycle 2 - IV Ondansetron
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Chemo cycle 1 - 600 mcg of delta-8-THC per dose Chemo cycle 2 - IV Ondansetron
Intervention Type
Drug
Intervention Name(s)
inhaled delta-8-THC 300mcg or 600mcg per dose
Other Intervention Name(s)
IV Ondansetron (comparator)
Intervention Description
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
Primary Outcome Measure Information:
Title
VAS scale for nausea
Description
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.
Time Frame
Up to 4 days after the patient receives chemotherapy. Measurements taken just before and 2 hours after inhalation morning and evening doses.
Secondary Outcome Measure Information:
Title
No. of emesis
Description
number of times patient vomits recorded daily after receiving cancer chemotherapy
Time Frame
up to the 4 days after patient receives chemotherapy
Title
VAS scale for delayed nausea
Description
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.
Time Frame
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.
Title
VAS scale for pain
Description
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.
Time Frame
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
Title
VAS scale for appetite stimulation
Description
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.
Time Frame
Up to 4 days after patient receives chemotherapy. Measurements are taken just before and 2 hours after taking inhalation morning and evening doses
Title
VAS scale for dizziness
Description
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.
Time Frame
before and 2 hours after taking inhalation, morning and evening doses.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Cherny, MD
Organizational Affiliation
Shaare Zedek Medical Center, Dept. of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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