Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients (NCT03339622) | Clinical Trial Compass
TerminatedPhase 3
Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients
Stopped: Mycotoxin potential contamination of one lot of study drug
Canada8 participantsStarted 2018-03-29
Plain-language summary
Cancer causes pain in many of the patients that it affects. Physicians specialized in palliative care help advanced cancer patients to maintain as good pain control as possible through the use of medications such as opioids. Even with palliative care and optimal use of medications, many patients still suffer enormously as the cancer spreads. Because of this, some cancer patients also try or use cannabis in different ways to relieve their pain and improve the way they feel. However, there has not been much high-quality research done yet to prove whether or not cannabis products are truly useful to relieve severe cancer pain. This study is to test if advanced cancer patients who use inhaled medical cannabis (PPP001), in addition to palliative care management, will experience improvement in quality of life and relieve uncontrolled pain, providing safety conditions.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent
✓. Adult male and female patients at least 18 years of age
✓. Subject agreed to follow the protocol
✓. Advanced cancer for which there is no known curative therapy
✓. Patients experiencing pain ≥4 on NRS due to cancer related pain
✓. Life expectancy six weeks or longer
✓. PPI score less than or equal to 4 (survival more than 6 weeks)
✓. PPS greater than or equal 70%
Exclusion criteria
✕. Pain due to other causes different than cancer related pain
✕. Previous serious adverse event or hypersensitivity to cannabis or cannabinoids
✕. Inability to understand and comply with the instructions of the study
What they're measuring
1
improve Health Related Quality of Life (HRQoL) of patients with uncontrolled cancer pain and incurable malignancy
Timeframe: Change from Baseline in HRQoL at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months.
✕. Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
✕. Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
✕. Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5
✕. Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids
✕. Current or history of suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS) approved by FDA in 2012 for assessment of suicidal ideation and behaviour