Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 (SERENITY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04001010
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
MedQualis
Information provided by (Responsible Party):
Tetra Bio-Pharma

Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date May 13, 2020
Estimated Study Start Date  ICMJE July 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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).
  • 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
  • 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. ]
    using a visual analogue scale. horizontal 0-100 mm VAS assessing pain
  • 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. ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2019)
  • 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).
  • 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.
  • The 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 scale for caregiver. Best rating on the left (Much more satisfied now) to worst rating on the right (Much Less satisfied now)
  • 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.
  • 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
  • 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
  • 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 PPP011. Opioids consumption will be measured using the oral morphine equivalent daily dose (MEDD).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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, ârellel Group Study
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cannabis Use
  • Cachexia; Cancer
  • Advanced Cancer
Intervention  ICMJE
  • Drug: PPP011
    1 capsule inhaled 3 times a day with a vaporizer device
    Other Name: CAUMZ
  • Drug: Placebo
    1 capsule inhaled 3 times a day with a vaporizer device
Study Arms  ICMJE
  • Experimental: inhaled THC/CBD (PPP011)
    PPP011 (synthetic THC/CBD) inhalation with mighty medic device
    Intervention: Drug: PPP011
  • Placebo Comparator: Placebo
    Placebo inhalation with mighty medic device
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2019)
334
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent,
  2. Adult male and female patients at least 18 years of age,
  3. Patient agreed to follow the protocol,
  4. Advanced cancer for which there is no known curative therapy,
  5. 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.
  6. Patient's weight 6 months before screening must be available
  7. Karnofsky Performance Status score ≥ 60 %
  8. Life expectancy of at least 4 months, excluding refractory cachexia
  9. No cognitive impairment according to Mini-Cog Negative confusion assessment according to CAM,
  10. The patient is able to perform deep inhalations with FEV1 more than 60%,
  11. Ability to read and respond to questions in French or English or French or Spanish,
  12. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chloe Colas +1 514 526-0626 ext 249 CColas@medqualis.com
Contact: Sophie Matharan, PhD +1 438 899 7575 ext 225 smatharan@tetrabiopharma.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT04001010
Other Study ID Numbers  ICMJE PPP011-Ph3-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tetra Bio-Pharma
Study Sponsor  ICMJE Tetra Bio-Pharma
Collaborators  ICMJE MedQualis
Investigators  ICMJE
Principal Investigator: Martin Chasen, MD William Osler Health Service Brampton
PRS Account Tetra Bio-Pharma
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP