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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


Phase 2
18 Years
85 Years
Not Enrolling
Both
Cancer

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Trial Information

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


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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

VAS scale for nausea

Principal Investigator

Nathan Cherny, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Shaare Zedek Medical Center, Dept. of Oncology

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

Rafa protocol THC002/NVP

NCT ID:

NCT00285051

Start Date:

November 2005

Completion Date:

November 2005

Related Keywords:

  • Cancer
  • emesis, nausea,
  • Nausea

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