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Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer (PLENITUDE)

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ClinicalTrials.gov Identifier: NCT04042545
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
Tetra Bio-Pharma

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Pain Quality of Life Pain, Acute Cannabis Use Drug: PPP001 Drug: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Experimental: inhaled THC/CBD (PPP001)
PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device
 Drug: PPP001
1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device
Other Name: QIXLEEF
Placebo Comparator: Placebo
Placebo inhalation with a device
 Drug: Placebo
1 placebo dosing capsule inhaled 3 times a day with a vaporizer device


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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).

  3. The palliative performance scale will be scored by a healthcare profesional. [ Time Frame: Change from Baseline in PPS at Weeks 1 and 4 ]
    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

  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 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).

  5. 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 ]
    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 .


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent,
  2. Adult male and female patients at least 18 years of age,
  3. Subject agreed to follow the protocol,
  4. Advanced cancer for which there is no known curative therapy as per investigator's judgement,
  5. Patients experiencing at least 2 symptoms related to cancer > 4 on ESAS-r-CS NRS including pain symptom,
  6. Life expectancy six weeks or longer with PPS > 50% and PaP Score Group A (30-day survival probability >70%),
  7. No cognitive impairment according to Mini-Cog©,
  8. The patient is able to perform deep inhalations with FEV1 more than 60%,
  9. Ability to read and respond to questions in English,

  10. 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,

  11. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042545


Contacts
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Contact: Tetra Bio Pharma +1(438)8997575

Locations
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United States, Arizona
Scottsdale Research Institute Recruiting
Cave Creek, Arizona, United States, 85331
Contact: Suzanne Sisley, MD         
Sponsors and Collaborators
Tetra Bio-Pharma
More Information
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Responsible Party: Tetra Bio-Pharma
ClinicalTrials.gov Identifier: NCT04042545    
Other Study ID Numbers: PPP001-Ph2-02
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cancer Pain
Acute Pain
Marijuana Abuse
Substance-Related Disorders
 Chemically-Induced Disorders
Mental Disorders
Pain
Neurologic Manifestations