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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

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

Condition or disease Intervention/treatment Phase
Cannabis Use Cachexia; Cancer Advanced Cancer Drug: PPP011 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 30, 2021

Arm Intervention/treatment
Experimental: inhaled THC/CBD (PPP011)
PPP011 (synthetic THC/CBD) inhalation with mighty medic device
Drug: PPP011
1 capsule inhaled 3 times a day with a vaporizer device
Other Name: CAUMZ

Placebo Comparator: Placebo
Placebo inhalation with mighty medic device
Drug: Placebo
1 capsule inhaled 3 times a day with a vaporizer device




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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. 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.


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): NCT04001010


Contacts
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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

Sponsors and Collaborators
Tetra Bio-Pharma
MedQualis
Investigators
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Principal Investigator: Martin Chasen, MD William Osler Health Service Brampton
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Responsible Party: Tetra Bio-Pharma
ClinicalTrials.gov Identifier: NCT04001010    
Other Study ID Numbers: PPP011-Ph3-01
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Neoplasms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders