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

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ClinicalTrials.gov Identifier: NCT04042545
Recruitment Status : Withdrawn (Modification of drug development program strategy at Tetra Bio-Pharma)
First Posted : August 2, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Tetra Bio-Pharma

Brief Summary:
This phase 2 clinical trial assess the safety and efficacy of a cannabinoid-based drug to releive 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 2 years. This is a single site study which takes place in the US.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 RELEIF IN PATIENTS WITH ADVANCED CANCER: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY
Estimated Study Start Date : January 29, 2020
Estimated Primary Completion Date : January 17, 2021
Estimated Study Completion Date : January 8, 2023

Arm Intervention/treatment
Experimental: inhaled THC/CBD (PPP001)
PPP001 (pellet with THC/CBD) inhalation with a device
Drug: PPP001
1 pellet inhaled 3 times a day with a vaporizer device
Other Name: QIXLEEF

Placebo Comparator: Placebo
Placebo inhalation with a device
Drug: Placebo
1 pellet inhaled 3 times a day with a vaporizer device




Primary Outcome Measures :
  1. Uncontrolled cancer pain will be measured using a patient self rating questionnaire. [ Time Frame: change from baseline in the EORTC-QLQ-C15-PAL pain multi-item scale score at Week 4. ]
    The uncontrolled cancer pain will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL) item 5 and 12. Scale range is 1 to 4; 1 (not at all) being the worst rating to the maximal rating of 4 (Very Much).


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 ]
    The QoL will be measured using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL) item 15. Scale range is 1 to 7; 1 (very poor) being the worst rating to the maximal rating of 7 (Excellent).

  2. The symptom burden will be measured using a patient self rating questionnaire. [ Time Frame: Change from Baseline in ESAS-r-CS at Weeks 1 and 4 ]
    The symptom burden will be measured using the revised Edmonton Symptom Assessment System version with Constipation and Sleep which was added to assess the improvement in symptom burden (ESAS-r-CS). Scale range is 0 to 10; 0 (No symptom) being the best rating to the maximal rating of 10 (Worst possible score for symptom).

  3. The functional status will be scored by a healthcare profesional. [ Time Frame: Change from Baseline in PPS at Weeks 1 and 4 ]
    The functional status will be scored using the Palliative Performance Scale (PPSv2) version 2. Each dimension will be scored by assigning a value from 100% (Full ability to interact and function) to 0% (death), with 10% denoting the lowest level of functioning.

  4. he satisfaction of family caregivers of patients with advanced cancer will be measured using a caregiver self rating 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 rating questionnaire [ Time Frame: Change from Baseline in distress thermometer at Week 4 ]
    The distress of patients will be measured using the distress thermometer a including a visual analogue scale from 0 (no distress) to 10 ( extreme distress) and proposals to check corresponding to the causes of the distress.

  6. The nutritional status of patients with advanced cancer will be measured using a patient self rating questionnaire [ Time Frame: Change from Baseline in PG-SGA at Week 4 ]
    The patient nutritional and functional assessment will be measured using the patient-generated-subjective global assessment (PG-SGA). The higher the score the greater the risk for malnutrition. A score ≥ 9 indicates a critical need for nutrition intervention

  7. The illness-understanding will be measured using a patient self rating questionnaire [ Time Frame: Change from Baseline in Brief IPQ at Week 4 ]
    The illness-understanding will be measured using the Brief Illness Perception Questionnaire (Breif IPQ) scores. Items are rated using a 0-to-10 response scale, 0 corresponding to the worst score and 10 the best score

  8. The total dose of concomitant medication to control cancer symptoms and pain will be recorded. [ Time Frame: Change from Baseline in concomitant medication at Weeks 1 and 4 ]
    The dosage of all medications taken by the patient in 24 hours will be recorded after starting treatment with PPP001. Opioids consumption will be measured using the oral morphine equivalent daily dose (MEDD)

  9. The cannabinoids concentration level will be measured [ Time Frame: Observed cannabinoids concentration level at baseline, week 1 and week 4, before and 1-hour after inhalation ]
    The cannabinoids concentration level will be measured by a blood sampling before inhalation and and 1 hour +/- 15 min after inhalation.



Information from the National Library of Medicine

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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. Negative confusion assessment according to CAM,
  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.

Exclusion Criteria:

  1. Previous serious adverse event or hypersensitivity to cannabis or cannabinoids,
  2. Inability to understand and comply with the instructions of the study and the inhalation procedure,
  3. 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,
  4. History of addiction or potential abuse substances confirmed by a positive urine drug screen for cannabinoids and other potential abuse substances (e.g. alcohol, cocaine, amphetamines, methamphetamines, MDMA and hallucinogens, but also unprescribed opioids and ketamine),
  5. Life-time history of schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids,
  6. Current or history of suicidal ideation,
  7. 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,
  8. Cancer patients may have increased liver enzymes or renal function impairment as a consequence of their disease. However, if at the screening time, there is evidence of grade equal or superior to 3 liver or kidney toxicity associated with their previous oncology treatment, they won't be allowed to be screened in the study. Patients won't be randomized if AST/ALT > 5 x ULN or Bilirubin > 3 x ULN or Creatinine > 3 x ULN before the baseline visit,
  9. Positive confusion assessment according to CAM,
  10. Patient has any planned clinical interventions or new curative cancer treatments (with the intent to cure the disease), but stabilised palliative therapies (e.g. chemotherapy, radiotherapy, immunotherapy, hormonotherapy) are allowed at a stable dosage if started at least 30 days before baseline,
  11. Epilepsy,
  12. The patient is currently using or has used cannabinoid-based medications within 30 days prior to the screening visit and is unwilling to abstain for the duration of the study. If the patient is an occasional cannabis user (Cannabis use in any form: 1-3 times/week) he or she must agree to a 7-day washout period where they will refrain from any cannabis use. After 1-week of cannabis abstinence, THC blood levels will be verified, and results must be negative, or the patient won't be randomized in the study,
  13. Curative cancer treatment wash-out period of less than 30 days before baseline,
  14. Participation in another clinical trial within 30 days prior to the enrolment in this trial.

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


Locations
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United States, Arizona
Scottsdale Research Institute
Scottsdale, Arizona, United States, 85260
Sponsors and Collaborators
Tetra Bio-Pharma

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Responsible Party: Tetra Bio-Pharma
ClinicalTrials.gov Identifier: NCT04042545     History of Changes
Other Study ID Numbers: PPP001-Ph2-02
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
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
Signs and Symptoms