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

• ClinicalTrials.gov Identifier: NCT00285051
• Recruitment Status: Terminated
• First Posted: February 1, 2006
• Last Update Posted: December 23, 2020
• Sponsor: Rafa Laboratories
• Collaborator: Teva Branded Pharmaceutical Products R&D, Inc.
• Information provided by (Responsible Party): Rafa Laboratories

Tracking Information

• First Submitted Date: January 31, 2006
• First Posted Date: February 1, 2006
• Last Update Posted Date: December 23, 2020
• Study Start Date: November 2005
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2020)

VAS scale for nausea [ Time Frame: Up to 4 days after the patient receives chemotherapy. Measurements taken just before and 2 hours after inhalation morning and evening doses. ]

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.

• Original Primary Outcome Measures (submitted: January 31, 2006): VAS scale for nausea

Current Secondary Outcome Measures (submitted: December 20, 2020)

• No. of emesis [ Time Frame: up to the 4 days after patient receives chemotherapy ]
  number of times patient vomits recorded daily after receiving cancer chemotherapy
• VAS scale for delayed nausea [ 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. ]
  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 [ 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 ]
  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 [ 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 ]
  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 [ Time Frame: before and 2 hours after taking inhalation, morning and evening doses. ]
  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.

Original Secondary Outcome Measures (submitted: January 31, 2006)

• No. of emesis
• VAS scale for delayed nausea
• VAS scale for pain
• VAS scale for appetite stimulation
• VAS scale for dizziness

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
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

Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment

• Condition: Cancer

Intervention

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

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

Other Name: IV Ondansetron (comparator)

Study Arms

• Experimental: Group 1
  Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 300 mcg of delta-8-THC per dose
  Intervention: Drug: inhaled delta-8-THC 300mcg or 600mcg per dose
• Experimental: Group 2
  Chemo cycle 1 - IV Ondansetron Chemo cycle 2 - 600 mcg of delta-8-THC per dose
  Intervention: Drug: inhaled delta-8-THC 300mcg or 600mcg per dose
• Experimental: Group 3
  Chemo cycle 1 - 300 mcg of delta-8-THC per dose, Chemo cycle 2 - IV Ondansetron
  Intervention: Drug: inhaled delta-8-THC 300mcg or 600mcg per dose
• Experimental: Group 4
  Chemo cycle 1 - 600 mcg of delta-8-THC per dose Chemo cycle 2 - IV Ondansetron
  Intervention: Drug: inhaled delta-8-THC 300mcg or 600mcg per dose

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 20, 2020): 6
• Original Enrollment (submitted: January 31, 2006): 108
• Actual Study Completion Date: February 2009
• Actual Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00285051
• Other Study ID Numbers: Rafa protocol THC002/NVP
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rafa Laboratories
• Original Responsible Party: Not Provided
• Current Study Sponsor: Rafa Laboratories
• Original Study Sponsor: Same as current
• Collaborators: Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

• Principal Investigator: Nathan Cherny, MD; Shaare Zedek Medical Center, Dept. of Oncology

• PRS Account: Rafa Laboratories
• Verification Date: April 2017