The buccal administration of a Cannabis sativa L./Cannabis indica L. extract as an adjunct to opioid analgesia for the management of intractable pain in patients diagnosed with advanced cancer: a safety, tolerability and exploratory end-point pilot study.
- Conditions
- CancerCancer - Any cancer
- Registration Number
- ACTRN12617001480370
- Lead Sponsor
- Medlab Clinical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Inclusion criteria Stage 1
1. Patient aged greater than 18 years.
2.Patient able to give informed consent and comply with study procedures.
3.Patient that has been diagnosed with an incurable malignancy.
4.Patient willing and able to receive an oro-buccal mucosa delivered medicine.
5.Patient willing to take a medication, which may exhibit psychoactive effects.
6.Patient agrees to abstain from using cannabis medicines other than the experimental drug for the duration of the clinical trial.
7.Patient agrees to not partake in any other interventional clinical treatments other than the ones that the treating clinical team are already aware of for the duration of the study.
8.Patient consents to provide blood samples for analysis throughout the duration of the clinical trial, whether participation is for Stage 1 only and or Stage 2.
9.Patient agrees to disclose that they are receiving an experimental medication to treating medical professionals who might be unaware of this fact.
10.Female of childbearing potential, agrees to use an effective form of birth control during the study participation.
11.Patient consents to having a baseline test for pregnancy if applicable.
12.Patient consents to having baseline tests for recent illicit substance use.
13.Patient agrees to still take regular doses of an opioid analgesic as prescribed. Patient should not cease opioid medications.
14.Patient agrees not to drive a car or other motor vehicle or operate any type of heavy machinery for 72 hours after the last dose of study medication.
Inclusion Criteria Stage 2
1.Patient aged greater than 18 years.
2.Patient able to give informed consent and comply with study procedures.
3.Patient that has been diagnosed with an incurable malignancy.
4.Patient reported experiencing moderate to severe pain.
5.Patient has been using strong opioid analgesics for at least one week to relieve pain associated with incurable malignancy (one-week prior use of opiate treatment is sufficient duration because it would represent established opioid treatment and most patients would have developed tolerance after one week, especially if it is given around the clock at a total daily dose of at least 60 mg of oral morphine or equivalent) and/or patient is on a low dose opioid regimen and still experiencing pain and is unable to increase the opioid dose due to poor tolerance as confirmed by the GP/specialist.
6.Patient report pain severity that is scored to be greater than a rating of 4 within a 0-10 Numerical Rating Scale (NRS) assessment tool.
7.Patient willing and able to receive an oromucosal delivered medicine.
8.Patient willing to take a medication, which may exhibit psychoactive effects.
9.Patient agrees to abstain from using cannabis medicines other than the experimental drug for the duration of the clinical trial.
10.Patient agrees to not partake in any other interventional clinical treatments other than the ones that the treating clinical team are already aware of for the duration of the study.
11.Patient consents to provide blood samples for analysis throughout the duration of the clinical trial, whether participation is for Stage 1 only and or Stage 2.
12.Patient agrees to disclose that they are receiving an experimental medication to treating medical professionals who might be unaware of this fact.
13.Female of childbearing potential, agrees to use an effective form of birth control
1.Patient engaged in medicinal or recreational use of any cannabinoid containing substance, in any form within the past 30 days.
2.Patient has a cognitive impairment or intellectual disability.
3.Patient has a history of primary psychotic disorder, bipolar affective disorder, bipolar disorder with psychotic features, depressive disorder with psychotic features, borderline personality disorder, antisocial personality disorder, or a positive family history (first degree relative) of psychotic disorder or bipolar affective disorder.
4.Patient has any history of allergic or hypersensitivity reaction to any herbal product, including cannabinoids.
5.Patient reports a prior sensitivity reaction to an oromucosal administered medicine or supplement (e.g., Liposomes).
6.Patient diagnosed with a head, neck, or oropharyngeal cancer will be considered for participation in the study at the discretion of the PI.
7.Patient has undergone any radiotherapy to the mouth or oral cavity.
8.Patient presents with any new unstable cardiovascular disorders (Coronary artery disease; heart attack; abnormal heart rhythms or arrhythmia; heart failure; heart valve disease; congenital heart disease; heart muscle disease; pericardial disease; aorta disease; vascular disease) that the PI assesses to be unsafe for the trial.
9.Patient has a history of epilepsy (or a previous history of seizures).
10.Patient has any clinically significant hepatic or renal impairment.
11.Patient diagnosed with brain metastasis will be considered for participation in the study at the discretion of the PI.
12.Patient is pregnant, lactating or partaking in sexual contact, which may result in pregnancy without adequate contraception.
13.Patient has received epidural analgesia within 48 hours of the baseline assessment
14.Patient has received any radiotherapy within two weeks of the initial baseline assessment.
15.Patient is currently administering Levodopa, Sildenafil (or any other PDE5s), anticonvulsants and/or Cannabinoids
16.Patient is currently receiving ketamine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite Primary Outcome<br>To investigate the safety, tolerability and pharmacokinetics (PK) of a cannabis (THC:CBD) extract by buccal administration in people with advanced cancer measured by:<br>-Clinical assessment including: recorded adverse events;<br>-The European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) Version 3;<br>-Laboratory assessments including pharmacokinetic data.<br>[- Participants will be monitored for adverse events by the Principal Investigator and/or research nurse throughout study period.<br>- EORTC QLQ-C30 Questionnaire to be completed daily by study participants in study stages 1 and 2.<br>- Blood samples collection for PK analysis at the following time points:<br>Stage 1<br>Day 1 - Baseline (0), 30, 60, 90, 120, 150, 180, 240, 360 minutes and 24 hours. <br>Day 2 - Baseline (0), 30, 60, 90, 120, 150, 180, 240, 360 minutes and 24 hours. <br>Stage 2<br>Blood samples collection (10 ml) on days 0, 4, 7, 10, 13, 16, 30]
- Secondary Outcome Measures
Name Time Method Composite Secondary Outcome<br>Exploratory pilot study to evaluate the analgesic effects of a THC:CBD extract as an adjunct to opioid analgesia in the management of pain in patients with moderate to severe cancer-related pain measured by:<br>-Numerical Pain Rating Scale (NPRS);<br>-Brief Pain Inventory, Short Form;<br>-MMeq doses;<br>-Rescue analgesia (opioid) requirement. <br>[- Numerical Pain Rating Scale (NPRS) to be completed daily by study participants in study stages 1 and 2.<br>- Brief Pain Inventory, Short Form to be completed daily by study participants in study stages 1 and 2.<br>- Morphine Milligram Equivalent doses to be recorded by study nurse daily on study stage 1 and on days 1, 4, 7, 10, 13, 16, 30 on study stage 2.<br>]