Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310750029454 Date of Approval: 31/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of cannabinoids on prostate specific antigen (PSA) and positron emission tomography/ computerized tomography (PET) scan results of patients diagnosed with prostate cancer who are using medical cannabis
Official scientific title The effect of cannabinoids on prostate specific antigen (PSA) and positron emission tomography/ computerized tomography (PET) scan results of patients diagnosed with prostate cancer who are using medical cannabis
Brief summary describing the background and objectives of the trial This is a prospective quantitative cohort research study, which aims to investigate the physiological effects cannabinoids have on the prostate specific antigen (PSA) and on the results of positron emission tomography (PET) scans on patients diagnosed with prostate cancer. Medical cannabis has been used globally for centuries, and has shown positive results on patients diagnosed with chronic ailments especially cancer (Frankhauser, 2002). Studies have shown the link between the medical cannabinoids and prostate cancer, and literature alludes to the fact that phytocannabinoids can be a possible treatment for patients diagnosed with prostate cancer (Leson & Pless, 2002). This study will utilise a quantitative research approach, and patients will be recruited from the cancer care centres in the Eastern Cape. This comparative study will evaluate three cohorts of patients. These include patients on medical cannabinoids only, patients receiving both medical cannabinoids and chemotherapy/ radiation, and the last group of patients using only the conventional chemotherapy/radiation. There is insufficient evidence to show the effect cannabinoids have on cancer patients, thus a conceptual framework/knowledge translation plan will be developed from the results of this study. Studies have indicated a relationship between the endocannabinoid system and the prostate cells (Andriole, Crawford & Grubb, 2009). Hence, this study will add to the growing body of knowledge and provide evidence on the effect of phytocannabinoids among prostate cancer patients.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 02/01/2022
Actual trial start date 01/05/2022
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date 30/04/2024
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Chemotherapy control group Chemotherapy/ brachytherapy only as per treatment from their oncologist. 6 months at baseline, then three months and six months The study will compare three exposure groups of patients; hence, stratified sampling technique will be used. The strata will be divided into patients who are using medical cannabis oil only, the second strata are those who are using both medical cannabis oil, as well as the conventional treatment such as chemotherapy/radiation and the third strata represents the control group, which include patients who are only using conventional treatment such as chemotherapy/radiation. This is the control group, the chemotherapy only group 30 Active-Treatment of Control Group
Experimental Group Cannabis only group 10-25 mg CBD and THC combined. Patients will either be making the medicines themselves hence self medicating, getting it from a traditional doctor, or getting it prescribed from their Drs as a section 21. 6 months of treatment, baseline and then monitored 3 months and 6 months The study will compare three groups of patients; hence, stratified sampling technique will be used. The strata will be divided into patients who are using medical cannabis oil only, the second strata are those who are using both medical cannabis oil, as well as the conventional treatment such as chemotherapy/radiation and the third strata represents the control group, which include patients who are only using conventional treatment such as chemotherapy/radiation. 30
Experimental Group Cannabis and chemotherapy group Patients will be receiving Brachytherapy as per their oncologist treatment as well as being on medical cannabis. The medical cannabis will be 10-20mg CBD and THC combined 6 months. patients will be monitored at baseline. 3 months and 6 months The study will compare three groups of patients; hence, stratified sampling technique will be used. The strata will be divided into patients who are using medical cannabis oil only, the second strata are those who are using both medical cannabis oil, as well as the conventional treatment such as chemotherapy/radiation and the third strata represents the control group, which include patients who are only using conventional treatment such as chemotherapy/radiation. This will be the cannabis and chemotherapy combined group 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 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. • 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. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 80 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2022 Institutional Research Ethics committee IREC
Ethics Committee Address
Street address City Postal code Country
Research and Postgraduate Support Directorate 2nd Floor, Berwyn Court Gate 1, Steve Biko Campus Durban University of Technology KZN 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. 3 and 6 months
Secondary Outcome 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. 3 and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Oncology Clinic 280 Oxford STreet East London 5200 South Africa
East London clinic Moore street East London 5200 South Africa
Holistic Healing Cannabis Clinic Stewart Drive East London 5241 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Cannabis Research Council Pearce Street East London 5241 South Africa
Durban University of Technology ML Sultan Road KZN 4000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cannabis Research Council Pearce Street east London 5200 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shiksha Gallow drgallow@hihealing.co.za +27829039779 Gonubie
City Postal code Country Position/Affiliation
East London 5200 South Africa Principal Investigator and lead researcher
Role Name Email Phone Street address
Public Enquiries Nosi Khelani info@hihealing.co.za +27685239253 Southernwoood
City Postal code Country Position/Affiliation
east London 5241 South Africa Research administrator
Role Name Email Phone Street address
Scientific Enquiries David Katere hwesa09@gmail.com +27618696817 Staatsartillerie Road
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Professor in Pharmacology and research collaborator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are committed to fostering transparency and promoting the responsible sharing of research data. In accordance with our data-sharing policy, we are pleased to provide access to individual participant data from our study titled "The effect of cannabinoids on prostate specific antigen (PSA) and positron emission tomography (PET) scan results of patients diagnosed with prostate cancer who are using medical cannabis" Data Sharing Policy: We adhere to the following principles regarding the sharing of individual participant data: Data Privacy and Confidentiality: We are dedicated to safeguarding the privacy and confidentiality of the data. Personal identifying information will be removed or anonymized to protect the identity of the participants. Access to Data: Individual participant data will be made available upon request, subject to review and approval by our Data Access Committee. Requests for data should be submitted to Nosi Khelani at info@hihealing.co.za Data Use Agreement: Researchers seeking access to the data will be required to sign a Data Use Agreement outlining the terms and conditions for data usage. This agreement will include commitments to protect data privacy, adhere to ethical standards, and properly acknowledge the source of the data. Publication Embargo: We respect the effort and time invested by our research team in generating this data. Therefore, an initial publication embargo of [2 years] will be imposed to allow our research team to complete their primary analyses and publish their findings. Data Access Fees: There may be fees associated with data access to cover the costs of data preparation, storage, and support services. Details regarding these fees can be obtained by contacting info@hihealing.co.za Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years The University will have access to the data as this forms part of a research PHD observational study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
n/a No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information