Metastatic Prostate CancerPhase 2NCT03763851
Cannabis Oil and Radiation Therapy for the Management of Pain
A Phase 2 study testing Active PPP005 and Radiotherapy in people with Metastatic Prostate Cancer and Lung Cancer, run by Tetra Bio-Pharma at 1 site in Canada.
Trial summary
In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Prostate Cancer, Lung Cancer, Breast Cancer
- What is being tested?
- Active PPP005 and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 14 Mar 2018to 30 Nov 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to consent to the study-specific written consent form, in English or French;
- Adult patients, male and female between the ages of 18 and 75 (inclusively);
- Patients with confirmed diagnosis of metastatic carcinoma of the prostate, lung or breast;
- No limitation with respect to number of metastases (bone and visceral);
- Location of metastases limited to exclude any brain metastases
- Patients experiencing an average weekly pain intensity score of 4 or higher on a 11 points NRS and requiring palliative RT;
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- KPS of equal or higher than 60;
- Subject agreed to follow the protocol;
- Patients who are referred to receive RT and are non-regular users of cannabis in any form (three times per week or more) and are willing to abstain for 1 week prior and during the study;
- Patients receiving opioids and other concomitant pain medications must have a stable dose for the last 15 days;
- Normal cognitive status according to MiniCog;
- Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
- Normal renal function (defined as serum creatinine level <133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) equal or higher than 60)
- Negative result on βhuman chorionic gonadotropin pregnancy test (if applicable)
- A female volunteer must meet one of the following criteria:
- If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first drug administration, during the study and for at least 60 days after the last dose.
- If of non-childbearing potential - should be surgically sterile or in a menopausal state
- A male volunteer with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must be surgically sterile or agrees to use one of the accepted contraceptive regimens from first drug administration until 3 months after the last drug administration.
Who cannot join
- Patients who are unable to consent or to comply with the instructions of the study;
- Patients suffering primarily from pain not related to cancer;
- KPS of < 60;
- Previous serious adverse event or hypersensitivity to cannabis or cannabinoids;
- 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);
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- 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 suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS);
- Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception;
- Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level >133 µmol/L.
- Cognitive impairment according to MiniCog;
- Current use of cannabis in any form more than 3 times per week or use of cannabinoid-based medications within 7 days of study entry and refusal to abstain for the duration of the study;
- Positive blood test for cannabinoids at screening or positive urine screening for other potential abuse substances (e.g. alcohol, cocaine, amphetamines and methamphetamines, unprescribed opioids);
- Participation in another clinical trial within 30 days of screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cannabis Oil and Radiation Therapy for the Management of Pain: Assessment of Safety and Efficacy in a Randomized, Double-blind Placebo-controlled Phase II/III Clinical Trial
In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Furthermore, the investigators will assess the effect of medical cannabis oil on health-related quality of life and symptoms that are frequently associated with metastatic cancers including fatigue, anxiety, depression, insomnia and decreased appetite. The safety profile of medical cannabis oil with respect to prolonged use of more than two weeks of administration, concomitant medication use and palliative RT will also be examined.
Read the detailed description
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate tolerability of medical cannabis oil to reduce chronic pain intensity.
Consecutive adult patients between the ages of 18 and 75, male and female, with cancer pain, with an average weekly pain intensity score greater than 4 on the 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial.
Informed consent will be obtained by a Research Assistant.
After baseline documentation with standardized scales, patients will be randomized to one of two parallel groups:
- Cannabis group: Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule
- Placebo group: Placebo capsule
- All patients will receive palliative RT to the symptomatic site. Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis.
Follow-up visits either in person or by phone will be at 1 week, 3 weeks and 6 weeks of treatment.
At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, patients will have the option to receive the active treatment during the 12-week open-label phase if the study physician feels it may potentially provide benefits. Similarly, the dose will be titrated up in the placebo group who wants to receive the active drug in the extension program.
The open-label phase is 12 weeks long. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
- Conditions
- Metastatic Prostate Cancer, Lung Cancer, Breast Cancer
- Being tested
- Active PPP005, Radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PPP005Radiation
Group assigned to active PPP005 in the randomized placebo-controlled trial
RadiotherapyRadiation
Palliative RadioTherapy to the symptomatic site
| Study group | Role | What they receive |
|---|---|---|
| Cannabis group | Experimental | Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule
These capsules contain different cannabis formulations with low-dose and high-dose preparations according to the treatment group:
* Cannabis group low-dose capsule contains THC 1mg CBD 1mg
* Cannabis group high-dose capsule contains THC 2.5mg CBD 2.5mg Receives: Radiation: Active PPP005; Radiation: Radiotherapy |
| Placebo group | Placebo comparator | The placebo capsule will have no cannabis, it will look identical to the active treatment capsule, and it will also be prepared in "low-dose" and "high-dose" presentations. Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer pain intensity assessed by Pain Intensity (PI) measurement a numerical rating scale
Pain Intensity (PI) measurement a Numerical Rating Scale (zero= no pain and 10= pain as bad as it can be).
A reduction of PI ≥ 33% will be considered as a clinically important level of pain relief
Measured: Change (a reduction of 30% in pain intensity) in pain intensity after medical cannabis oil administration compared to placebo at 6 weeks compared to baseline
Cancer pain quality using the Brief Pain Inventory-SF (BPI-SF)
The BPI-SF consists of nine questions; eight have a single response, and Question 9 is subdivided into seven parts. The Total BPI for Question 9 is the unweighted sum of the seven assessments and represents the effect of pain
Measured: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Secondary outcomes (4)
Impact of medical cannabis oil combined with radiation treatment on HRQoL as measured by the EQ-5D-5L
Measured: at baseline, 1-week, 3-week, and 6-week follow-up
Functional status assessed by the Functional Assessment of Cancer Therapy for Prostate patients (FACT-P).
Measured: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Fatigue burden assessed by the Brief Fatigue Inventory (BFI).
Measured: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Cognitive status assessed by the Mini-Cog
Measured: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start14 Mar 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Why it stopped: due to mycotoxin potential contamination of one lot of study drug
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetra Bio-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Santé Cannabis, McGill University
- Responsible party
- Sponsor
- Investigators
- Tamim Niazi, MD, Principal investigator, Jewish General Hospital, McGill UniversityJean Zigby, MD, Principal investigator, Jewish General Hospital, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763851
- Sponsor's protocol ID
- PPP005-Ph2/3-01
- Status last verified
- Mar 2020
- First submitted
- 12 Nov 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis Oil and Radiation Therapy for the Management of Pain: Assessment of Safety and Efficacy in a Randomized, Double-blind Placebo-controlled Phase II/III Clinical Trial
- ClinicalTrials.gov ID
- NCT03763851
- Acronym / sponsor ID
- PPP005-Ph2/3-01
- Conditions
- Metastatic Prostate Cancer, Lung Cancer, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to mycotoxin potential contamination of one lot of study drug
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tetra Bio-PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Santé Cannabis, McGill University
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this innovative approach seeking effective therapeutic strategies, the investigators are proposing to test the effectiveness of medical cannabis oil as an adjunct to palliative Radiation Therapy (RT) and Best Supportive Care to alleviate cancer pain that was only partially relieved with conventional medications. Furthermore, the investigators will assess the effect of medical cannabis oil on health-related quality of life and symptoms that are frequently associated with metastatic cancers including fatigue, anxiety, depression, insomnia and decreased appetite. The safety profile of medical cannabis oil with respect to prolonged use of more than two weeks of administration, concomitant medication use and palliative RT will also be examined.
Detailed description
This is a 6-week randomized, double-blind, placebo-controlled, parallel group design trial followed by an open-label extension phase of 12 weeks, to evaluate tolerability of medical cannabis oil to reduce chronic pain intensity.
Consecutive adult patients between the ages of 18 and 75, male and female, with cancer pain, with an average weekly pain intensity score greater than 4 on the 11 points Numerical Rate Scale (NRS), will be prospectively recruited and invited to participate in this trial.
Informed consent will be obtained by a Research Assistant.
After baseline documentation with standardized scales, patients will be randomized to one of two parallel groups:
- Cannabis group: Delta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule
- Placebo group: Placebo capsule
- All patients will receive palliative RT to the symptomatic site. Patients will have a dose titration phase during the first week. The dose escalation will allow patients to adapt to the potential adverse effects (AEs) of the medical cannabis.
Follow-up visits either in person or by phone will be at 1 week, 3 weeks and 6 weeks of treatment.
At the end of the first phase of the study, patients who wish to participate in the open-label extension phase will have the option to continue in the same treatment regimen. For the placebo group, patients will have the option to receive the active treatment during the 12-week open-label phase if the study physician feels it may potentially provide benefits. Similarly, the dose will be titrated up in the placebo group who wants to receive the active drug in the extension program.
The open-label phase is 12 weeks long. For this open-label extension phase the follow-up visits will be done after 4 weeks and 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis group | Experimental | Radiation: Active PPP005, Radiation: RadiotherapyDelta-9 Tetrahydrocannabidiol (THC) /Cannabidiol (CBD) ratio 1:1 capsule These capsules contain different cannabis formulations with low-dose and high-dose preparations according to the treatment group: * Cannabis group low-dose capsule contains THC 1mg CBD 1mg * Cannabis group high-dose capsule contains THC 2.5mg CBD 2.5mg |
| Placebo group | Placebo comparator | Radiation: RadiotherapyThe placebo capsule will have no cannabis, it will look identical to the active treatment capsule, and it will also be prepared in "low-dose" and "high-dose" presentations. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Ability to consent to the study-specific written consent form, in English or French;
- Adult patients, male and female between the ages of 18 and 75 (inclusively);
- Patients with confirmed diagnosis of metastatic carcinoma of the prostate, lung or breast;
- Patients experiencing an average weekly pain intensity score of 4 or higher on a 11 points NRS and requiring palliative RT;
- KPS of equal or higher than 60;
Key exclusion criteria (15 listed)
- Patients who are unable to consent or to comply with the instructions of the study;
- Patients suffering primarily from pain not related to cancer;
- KPS of < 60;
- Previous serious adverse event or hypersensitivity to cannabis or cannabinoids;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active PPP005Group assigned to active PPP005 in the randomized placebo-controlled trial | Radiation | Cannabis group |
| RadiotherapyPalliative RadioTherapy to the symptomatic site | Radiation | Cannabis group, Placebo group |
Primary outcome
Cancer pain intensity assessed by Pain Intensity (PI) measurement a numerical rating scale
Time frame: Change (a reduction of 30% in pain intensity) in pain intensity after medical cannabis oil administration compared to placebo at 6 weeks compared to baseline
Pain Intensity (PI) measurement a Numerical Rating Scale (zero= no pain and 10= pain as bad as it can be). A reduction of PI ≥ 33% will be considered as a clinically important level of pain relief
Cancer pain quality using the Brief Pain Inventory-SF (BPI-SF)
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
The BPI-SF consists of nine questions; eight have a single response, and Question 9 is subdivided into seven parts. The Total BPI for Question 9 is the unweighted sum of the seven assessments and represents the effect of pain
4 secondary outcomes
Impact of medical cannabis oil combined with radiation treatment on HRQoL as measured by the EQ-5D-5L
Time frame: at baseline, 1-week, 3-week, and 6-week follow-up
Functional status assessed by the Functional Assessment of Cancer Therapy for Prostate patients (FACT-P).
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Fatigue burden assessed by the Brief Fatigue Inventory (BFI).
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Cognitive status assessed by the Mini-Cog
Time frame: The measurements will be completed at baseline before initiating treatment and at week 1, week 3 and week 6 after starting treatment
Results and safety
The study was stopped early (reason given: due to mycotoxin potential contamination of one lot of study drug). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamim Niazi, MD principal investigator
Jewish General Hospital, McGill University
Jean Zigby, MD principal investigator
Jewish General Hospital, McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active PPP005 and Radiotherapy in people with Metastatic Prostate Cancer and Lung Cancer, run by Tetra Bio-Pharma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: due to mycotoxin potential contamination of one lot of study drug). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer pain intensity assessed by Pain Intensity (PI) measurement a numerical rating scale (time frame: Change (a reduction of 30% in pain intensity) in pain intensity after medical cannabis oil administration compared to placebo at 6 weeks compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.