Cancer
Conditions
Interventions
Chemotherapy control group
Cannabis only group
Cannabis and chemotherapy group
Sponsors
Cannabis Research Council
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Patients who have been diagnosed with prostate cancer as the primary cancer. • Patients who have had radiation and /or chemotherapy and are self-medicating on medical cannabis oil for more than a period of 3 months; or • Patients who have not had any radiation and/ or chemotherapy and are still self-medicating on medical cannabis oil more than a period of 3 months; or • Patients receiving radiation and/ chemotherapy only, and not taking any medical cannabis oil more than a period of 3 months. • Patients making their own cannabis oil will be included in the study, provided the THC and CBD in the cannabinoid profile is between 10 mg to 20 mg for both CBD and THC. • Participants taking proprietary cannabis oils approved for medicinal use in hand in terms of a Section 21 exclusion, provided the CBD and THC range between 10 mg to 20 mg.
Exclusion criteria
Exclusion criteria: • Patients younger than 21 years of age. • Patients who are deemed palliative in nature (expectation of passing in less than six months). • Patients who are diagnosed with Schizophrenia or any other psychotic disorders. • Stage one prostate cancer. • Patients who had a Prostatectomy. • Patients smoking cannabis. • Participants of the pilot study. • Participants who will not give written informed consent. • Participants who will not provide the cannabis oil they use for testing. • Patients using cannabis recreationally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To investigate the effects of cannabinoids alone, or in combination with chemotherapy versus chemotherapy only on PSA measurements in adult males with prostate cancer. 2)To investigate the effects of cannabinoids alone, or in combination with chemotherapy versus chemotherapy only on size of tumour in males with prostate cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To investigate the effects of cannabinoids alone, or in combination with chemotherapy versus chemotherapy only on quality of life measurements in adult males with prostate cancer. 2) To investigate the effects of cannabinoids alone, or in combination with chemotherapy versus chemotherapy only on pain management in males with prostate cancer. 3) To develop a framework/knowledge translation plan using the findings of the research for patients who have prostate cancer as well as health care providers. | — |
Countries
South Africa
Contacts
Public ContactNosi Khelani
Research administrator
Outcome results
None listed