Clinical evidence is urgently needed to be able to advise patients on which cannabis-based
products to take, or to avoid, in managing cancer-related symptoms. This trial was therefore
designed to determine which cannabis extract combination (High THC-Low CBD, Low THC-High CBD,
or Equal amounts of THC and CBD) is most effective at treating cancer related symptoms for
each patient relative to placebo. Investigators propose a randomized, double-blind, N-of-1
trial to test the effectiveness of each cannabis extract combination using cannabis oils in a
minimum of 120 patients on 4 cancer-related symptoms: nausea, pain, anxiety and sleep
disturbance.
The three active treatments will be the following cannabis oil extract combinations: High
THC/Low CBD, Low THC/High CBD, and Equal amounts of THC/CBD.
- THC = Tetrahydrocannabinol
- CBD = Cannabidiol
The placebo treatment will be coconut/olive oil. The overpowering flavor of the olive oil in
the active oils and the placebo will effectively blind subjects.
Primary objective:
To identify whether there is an active cannabis extract that is more effective than placebo
in managing overall cancer-related symptoms for individual subjects who completed at least 1
treatment cycle for the entire patient population represented by those individual subjects,
and for subsets of that subject population defined by relevant baseline patient
characteristics.
Secondary objective:
To identify whether there is a cannabis extract that is more effective than placebo in
managing each of the 4 index symptoms (pain, nausea, anxiety and sleep disturbance) for
individual subjects who completed at least 1 treatment cycle, for the entire patient
population represented by those individual subjects, and for subsets of that subject
population defined by relevant baseline patient characteristics.
Tertiary objectives:
To investigate the safety (e.g., serious adverse events) of each of the three cannabis
extracts.
To identify subject preference of each of the 4 oils (if any).