Oral Medicinal Cannabis (CBD:THC) as Add-On to Standard of Care for Symptomatic and Palliative Treatment in Cancer Patients - a Multicentre Prospective Patient Registry in Switzerland and Germany.
- Conditions
- cancer related symptoms and/or chemotherapy or radiation therapy related symptoms (e.g. chemotherapy-induced nausea and vomiting, pain, sleep problems, appetite loss)
- Registration Number
- DRKS00028190
- Lead Sponsor
- Stiftung Swiss Tumor Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Written informed consent;
- Adult male and female patients > 18 years suffering from cancer related and/or chemotherapy or radiation therapy related symptoms;
- Patients who have not been previously treated with a medical cannabis product for cancer related and/or chemotherapy or radiation therapy related symptoms but now are scheduled for a treatment with cannabinoids;
- Using the consilium careTM App on their personal smartphone (Android or iOS system) as part of the routine medical data assessment;
- No cognitive impairment as judged by the treating physician;
- Ability to read and answer questions in German.
Patients who are in the opinion of the investigator unsuitable for participation in the registry for any other reason not listed in the inclusion and exclusion criteria.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To get insights from therapy with CBD:THC products added to SoC for supportive and palliative treatment of cancer related and/or chemotherapy or radiation therapy related symptoms in daily clinical practice under real world conditions.
- Secondary Outcome Measures
Name Time Method Developing a data pool for future research questions.<br>Capturing patient data continuously during medical cannabis-treatment to get insights on:<br>- treatment pathways,<br>- duration of medical cannabis treatment,<br>- proportion of chemotherapy patients for whom guideline-compliant treatment of CINV is insufficient,<br>- proportion of patients suffering from further cancer related and/or chemotherapy or radiation therapy related symptoms,<br>- proportion of cancer patients receiving cannabis in total and per center,<br>- proportion of patients for whom cannabis results in relief of their symptoms,<br>- reasons for withdrawal from medical cannabis therapy,<br>- information on related symptoms, e.g., appetite loss, anxiety, pain and sleep problems,<br>- change in concomitant medications,<br>- development of quality of life, <br>- data on optimal dose titration.