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

Primary Purpose

Cancer Pain, Quality of Life, Pain, Acute

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PPP001
Placebo
Sponsored by
Tetra Bio-Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scottsdale Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

inhaled THC/CBD (PPP001)

Placebo

Arm Description

PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device

Placebo inhalation with a device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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).
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
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).
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 .

Full Information

First Posted
July 31, 2019
Last Updated
September 13, 2021
Sponsor
Tetra Bio-Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04042545
Brief Title
Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer
Acronym
PLENITUDE
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tetra Bio-Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain, Quality of Life, Pain, Acute, Cannabis Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inhaled THC/CBD (PPP001)
Arm Type
Experimental
Arm Description
PPP001 (cannabis dosing capsule with THC/CBD) inhalation with a device
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo inhalation with a device
Intervention Type
Drug
Intervention Name(s)
PPP001
Other Intervention Name(s)
QIXLEEF
Intervention Description
1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 placebo dosing capsule inhaled 3 times a day with a vaporizer device
Primary Outcome Measure Information:
Title
Uncontrolled cancer pain will be measured using a patient self-administered questionnaire.
Description
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
Time Frame
change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4.
Secondary Outcome Measure Information:
Title
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.
Description
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
Time Frame
change from baseline in the EORTC-QLQ-C15-PAL overall QoL single-item scale score at Week 4
Title
The physical, emotional, and total symptom distress will be measured using a patient self administered questionnaire.
Description
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).
Time Frame
Change from Baseline in ESAS-r-CS at Weeks 1 and 4
Title
The palliative performance scale will be scored by a healthcare profesional.
Description
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
Time Frame
Change from Baseline in PPS at Weeks 1 and 4
Title
The satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self administered questionnaire.
Description
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).
Time Frame
Change from Baseline in treatment-satisfaction questionnaire at Weeks 1 and 4
Title
The distress of patients with advanced cancer will be measured using a patient self-administered questionnaire
Description
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 .
Time Frame
Change from Baseline in distress thermometer at Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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%), 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tetra Bio Pharma
Phone
+1(438)8997575
Facility Information:
Facility Name
Scottsdale Research Institute
City
Cave Creek
State/Province
Arizona
ZIP/Postal Code
85331
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Sisley, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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