Cancer PainPhase 2PLENITUDENCT04042545
Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer
A Phase 2 study testing PPP001 in people with Cancer Pain and Quality of Life, run by Tetra Bio-Pharma at 1 site in United States.
Trial summary
This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Quality of Life, Pain, Acute
- What is being tested?
- PPP001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2020to Sep 2022
- 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 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,
- Subject agreed to follow the protocol,
- Advanced cancer for which there is no known curative therapy as per investigator's judgement,
- Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom,
- Life expectancy six weeks or longer with PPS > 50% and PaP Score Group A (30-day survival probability >70%),
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- No cognitive impairment according to Mini-Cog©,
- The patient is able to perform deep inhalations with FEV1 more than 60%,
- Ability to read and respond to questions in English,
- 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.
Tetra Bio Pharma contact
United States1 site, 1 recruiting
- Recruiting
Scottsdale Research Institute
Cave Creek, Arizona, 85331
Suzanne Sisley, MD
About this study
Official title: SAFETY AND EFFICACY OF PPP001-kit FOR THE UNCONTROLLED PAIN RELIEF IN PATIENTS WITH ADVANCED CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY
This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.
Read the detailed description
This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms related to advanced incurable cancer.
- Conditions
- Cancer Pain, Quality of Life, Pain, Acute, Cannabis Use
- Being tested
- PPP001, Placebo
- Medical subject headings
- Cancer Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPP001Drug
Also called QIXLEEF
1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device
PlaceboDrug
1 placebo dosing capsule inhaled 3 times a day with a vaporizer device
| Study group | Role | What they receive |
|---|---|---|
| inhaled THC/CBD (PPP001) | Experimental | PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device Receives: Drug: PPP001 |
| Placebo | Placebo comparator | Placebo inhalation with a device Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncontrolled cancer pain will be measured using a patient self-administered 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 the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.
Secondary outcomes (5)
The overall HRQoL (Health related Quality of Life) of patients with uncontrolled symptoms 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). single-item scale is rated from 1 (very poor) to 7 (excellent). High scores on a functional scale correspond to better functioning
Measured: change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4
The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire.
Revised Edmonton Symptom Assessment System (ESAS-r-CS). 11 core symptoms: pain, tiredness, nausea, depression, anxious, drowsiness, appetite, feeling of well-being, shortness of breath, constipation and trouble sleeping. 11-point NRS ranging from 0 (no symptom) to 10 (worst possible).
Measured: Change from Baseline in ESAS-r-CS at Weeks 1 and 4
The palliative performance scale will be scored by a healthcare profesional.
palliative performance scale version 2 (PPSv2) for measuring functional status in end-of-life patients. A healthcare professional scores each dimension by assigning a value from 100% to 0% (death), with 10% denoting the lowest level of functioning
Measured: Change from Baseline in PPS at Weeks 1 and 4
The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire.
The treatment satisfaction questionnaire (change version) will be used. Scale range is a left to right 7-item scale for caregiver. each item is scored from 5 (Much more satisfied now) to 1 (Much Less satisfied now).
Measured: Change from Baseline in treatment-satisfaction questionnaire at Weeks 1 and 4
The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire
distress thermometer adopted as a screening measure to identify and address psychological distress in individuals with cancer. Results support a cut-off score of 3 on the DT to indicate patients with clinically elevated levels of distress .
Measured: Change from Baseline in distress thermometer at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start30 Jul 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tetra Bio-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042545
- Sponsor's protocol ID
- PPP001-Ph2-02
- Acronym
- PLENITUDE
- Status last verified
- Feb 2021
- First submitted
- 31 Jul 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFETY AND EFFICACY OF PPP001-kit FOR THE UNCONTROLLED PAIN RELIEF IN PATIENTS WITH ADVANCED CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY
- ClinicalTrials.gov ID
- NCT04042545
- Acronym / sponsor ID
- PLENITUDE / PPP001-Ph2-02
- Conditions
- Cancer Pain, Quality of Life, Pain, Acute, Cannabis Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Tetra Bio-PharmaIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 2 Aug 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.
This phase 2 multicenter clinical trial assess the safety and efficacy of inhaled PPP001 to relieve the pain in 78 advanced cancer patients with uncontrolled symptoms. This is a 4-week treatment period study followed by an open label period of 1 year.
Detailed description
This is a 4-week randomized, double-blind, placebo-controlled, parallel group design trial to evaluate the safety and efficacy of inhaled PPP001 on uncontrolled cancer pain in patients with symptoms 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 (PPP001) | Experimental | Drug: PPP001PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhalation with a device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 as per investigator's judgement,
- Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom,
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 |
|---|---|---|
| PPP001Also: QIXLEEF1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device | Drug | inhaled THC/CBD (PPP001) |
| Placebo1 placebo dosing capsule inhaled 3 times a day with a vaporizer device | Drug | Placebo |
Primary outcome
Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.
Time frame: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.
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
5 secondary outcomes
The overall HRQoL (Health related Quality of Life) of patients with uncontrolled symptoms related to advanced cancer will be measured using a patient self rating questionnaire.
Time frame: change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4
The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire.
Time frame: Change from Baseline in ESAS-r-CS at Weeks 1 and 4
The palliative performance scale will be scored by a healthcare profesional.
Time frame: Change from Baseline in PPS at Weeks 1 and 4
The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire.
Time frame: Change from Baseline in treatment-satisfaction questionnaire at Weeks 1 and 4
The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire
Time frame: Change from Baseline in distress thermometer at Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Tetra Bio Pharma contact
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 PPP001 in people with Cancer Pain and Quality of Life, run by Tetra Bio-Pharma at 1 site in United States.
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 12 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: status not confirmed, as of the sponsor's last update on 16 Sep 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tetra Bio Pharma (+1(438)8997575), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncontrolled cancer pain will be measured using a patient self-administered questionnaire. (time frame: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.). 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 16 Sep 2021.