Cannabis UsePhase 3SERENITYNCT04001010
Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia
A Phase 3 study testing PPP011 in people with Cannabis Use and Cachexia; Cancer, run by Tetra Bio-Pharma at 1 site in Canada.
Trial summary
A large number of patients with advanced cancer also suffer from cachexia. Cachexia is a syndrome characterized by loss of skeletal muscle mass (with/or without loss of fat mass) that cannot be reversed by nutritional support and progressively leads to functional impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis Use, Cachexia; Cancer, Advanced Cancer
- What is being tested?
- PPP011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 334 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2022to Dec 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent,
- Adult male and female patients at least 18 years of age,
- Patient agreed to follow the protocol,
- Advanced cancer for which there is no known curative therapy,
- The patient has a cachexia weight loss of Grade of 2 or Grade 3 cachexia as follow (based on Weight Loss Grading System) Weight loss accounts for the last 6 months before screening.
- Patient's weight 6 months before screening must be available
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- Karnofsky Performance Status score ≥ 60 %
- Life expectancy of at least 4 months, excluding refractory cachexia
- No cognitive impairment according to Mini-Cog Negative confusion assessment according to CAM,
- The patient is able to perform deep inhalations with FEV1 more than 60%,
- Ability to read and respond to questions in French or English or French or Spanish,
- 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
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of PPP011-kit for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia: a Randomized, Double Blind, Placebo Controlled, Parallel Group Study
A large number of patients with advanced cancer also suffer from cachexia. Cachexia is a syndrome characterized by loss of skeletal muscle mass (with/or without loss of fat mass) that cannot be reversed by nutritional support and progressively leads to functional impairment. Patients who suffer from anorexia and cachexia have lower survival rates. Some patients with cancer use cannabis to improve the way they feel and relieve their pain. However, there is very sparse high-quality research to prove that cannabis products are truly effective. This study will investigate patients with advanced cancer who use inhaled therapeutic cannabinoid-based medication (PPP011), in addition to palliative care management, and will assess if these patients experience improvement in functional status as a surrogate endpoint for survivalquality
Read the detailed description
This is a 12-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP011 on physical functioning and cachexia progression in patients with cachexia related to advanced incurable cancer.
- Conditions
- Cannabis Use, Cachexia; Cancer, Advanced Cancer
- Being tested
- PPP011, Placebo
- Medical subject headings
- Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPP011Drug
Also called CAUMZ
1 capsule inhaled 3 times a day with a vaporizer device
PlaceboDrug
1 capsule inhaled 3 times a day with a vaporizer device
| Study group | Role | What they receive |
|---|---|---|
| inhaled THC/CBD (PPP011) | Experimental | PPP011 (synthetic THC/CBD) inhalation with mighty medic device Receives: Drug: PPP011 |
| Placebo | Placebo comparator | Placebo inhalation with mighty medic device Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical functioning related to advanced cancer will be measured using a patient self rating questionnaire.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). items are rated on a scale of 1 (not at all) to 4 (very much). high scores on a symptom scale correlate to increased symptom burden
Measured: Change from baseline in EORTC-QLQ-C15-PAL physical functioning in multi-item scales at week 4, 8 and 12 W4 W8 W12
Cachexia grade will be measured as per Weight Loss Grading System
Downgrading cachexia grade or grade maintenance will be considered as a drug benefit.
Measured: Change from baseline at week 4, 8 and 12.
Secondary outcomes (2)
pain will be recorded: VAS
using a visual analogue scale. horizontal 0-100 mm VAS assessing pain
Measured: Observed and Change from baseline in a VAS on pain AND no increase in pain medications at week 4, 8 and, 12 and 24.
Patient nutritional and functional assessment will be meseared using a patient self rating questionnaire
Patient-generated-subjective global assessment (PG-SGA) where critical need for nutrition intervention is defined as having a score ≥ 9 The higher the score the greater the risk for malnutrition
Measured: Observed and change from baseline in patient nutritional and functional assessment (PG-SGA) at baseline and week 4, 8 and, 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study startJul 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Study is postponed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tetra Bio-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Chasen, MD, Principal investigator, William Osler Health Service Brampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001010
- Sponsor's protocol ID
- PPP011-Ph3-01
- Acronym
- SERENITY
- Status last verified
- Feb 2021
- First submitted
- 31 May 2019
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of PPP011-kit for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia: a Randomized, Double Blind, Placebo Controlled, Parallel Group Study
- ClinicalTrials.gov ID
- NCT04001010
- Acronym / sponsor ID
- SERENITY / PPP011-Ph3-01
- Conditions
- Cannabis Use, Cachexia; Cancer, Advanced Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is postponed
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Tetra Bio-PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jun 2019 (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.
A large number of patients with advanced cancer also suffer from cachexia. Cachexia is a syndrome characterized by loss of skeletal muscle mass (with/or without loss of fat mass) that cannot be reversed by nutritional support and progressively leads to functional impairment. Patients who suffer from anorexia and cachexia have lower survival rates. Some patients with cancer use cannabis to improve the way they feel and relieve their pain. However, there is very sparse high-quality research to prove that cannabis products are truly effective. This study will investigate patients with advanced cancer who use inhaled therapeutic cannabinoid-based medication (PPP011), in addition to palliative care management, and will assess if these patients experience improvement in functional status as a surrogate endpoint for survivalquality
Detailed description
This is a 12-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP011 on physical functioning and cachexia progression in patients with cachexia related to advanced incurable cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhaled THC/CBD (PPP011) | Experimental | Drug: PPP011PPP011 (synthetic THC/CBD) inhalation with mighty medic device |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhalation with mighty medic device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent,
- Adult male and female patients at least 18 years of age,
- Patient agreed to follow the protocol,
- Advanced cancer for which there is no known curative therapy,
- The patient has a cachexia weight loss of Grade of 2 or Grade 3 cachexia as follow (based on Weight Loss Grading System) Weight loss accounts for the last 6 months before screening.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PPP011Also: CAUMZ1 capsule inhaled 3 times a day with a vaporizer device | Drug | inhaled THC/CBD (PPP011) |
| Placebo1 capsule inhaled 3 times a day with a vaporizer device | Drug | Placebo |
Primary outcome
physical functioning related to advanced cancer will be measured using a patient self rating questionnaire.
Time frame: Change from baseline in EORTC-QLQ-C15-PAL physical functioning in multi-item scales at week 4, 8 and 12 W4 W8 W12
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). items are rated on a scale of 1 (not at all) to 4 (very much). high scores on a symptom scale correlate to increased symptom burden
Cachexia grade will be measured as per Weight Loss Grading System
Time frame: Change from baseline at week 4, 8 and 12.
Downgrading cachexia grade or grade maintenance will be considered as a drug benefit.
2 secondary outcomes
pain will be recorded: VAS
Time frame: Observed and Change from baseline in a VAS on pain AND no increase in pain medications at week 4, 8 and, 12 and 24.
Patient nutritional and functional assessment will be meseared using a patient self rating questionnaire
Time frame: Observed and change from baseline in patient nutritional and functional assessment (PG-SGA) at baseline and week 4, 8 and, 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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.
Martin Chasen, MD principal investigator
William Osler Health Service Brampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PPP011 in people with Cannabis Use and Cachexia; 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 13 inclusion and 0 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: paused, as of the sponsor's last update on 5 Feb 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
physical functioning related to advanced cancer will be measured using a patient self rating questionnaire. (time frame: Change from baseline in EORTC-QLQ-C15-PAL physical functioning in multi-item scales at week 4, 8 and 12 W4 W8 W12). 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 5 Feb 2021.