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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)

Primary Purpose

Cannabis Use, Cachexia; Cancer, Advanced Cancer

Status
Suspended
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
PPP011
Placebo
Sponsored by
Tetra Bio-Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use

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. 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.

Sites / Locations

  • William Osler Health Service Brampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

inhaled THC/CBD (PPP011)

Placebo

Arm Description

PPP011 (synthetic THC/CBD) inhalation with mighty medic device

Placebo inhalation with mighty medic device

Outcomes

Primary Outcome Measures

physical functioning 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). 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
Downgrading cachexia grade or grade maintenance will be considered as a drug benefit.

Secondary Outcome Measures

pain will be recorded: VAS
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
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

Full Information

First Posted
May 31, 2019
Last Updated
February 2, 2021
Sponsor
Tetra Bio-Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT04001010
Brief Title
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
Acronym
SERENITY
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, Parallel Group Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Suspended
Why Stopped
Study is postponed
Study Start Date
July 2022 (Anticipated)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Cachexia; Cancer, Advanced Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
inhaled THC/CBD (PPP011)
Arm Type
Experimental
Arm Description
PPP011 (synthetic THC/CBD) inhalation with mighty medic device
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo inhalation with mighty medic device
Intervention Type
Drug
Intervention Name(s)
PPP011
Other Intervention Name(s)
CAUMZ
Intervention Description
1 capsule inhaled 3 times a day with a vaporizer device
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule inhaled 3 times a day with a vaporizer device
Primary Outcome Measure Information:
Title
physical functioning 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). 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 EORTC-QLQ-C15-PAL physical functioning in multi-item scales at week 4, 8 and 12 W4 W8 W12
Title
Cachexia grade will be measured as per Weight Loss Grading System
Description
Downgrading cachexia grade or grade maintenance will be considered as a drug benefit.
Time Frame
Change from baseline at week 4, 8 and 12.
Secondary Outcome Measure Information:
Title
pain will be recorded: VAS
Description
using a visual analogue scale. horizontal 0-100 mm VAS assessing pain
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.
Title
Patient nutritional and functional assessment will be meseared using a patient self rating questionnaire
Description
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
Time Frame
Observed and change from baseline in patient nutritional and functional assessment (PG-SGA) at baseline and week 4, 8 and, 12.

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, Patient agreed to follow the protocol, Advanced cancer for which there is no known curative therapy, 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. Patient's weight 6 months before screening must be available Karnofsky Performance Status score ≥ 60 % Life expectancy of at least 4 months, excluding refractory cachexia No cognitive impairment according to Mini-Cog Negative confusion assessment according to CAM, The patient is able to perform deep inhalations with FEV1 more than 60%, Ability to read and respond to questions in French or English or French or Spanish, 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Chasen, MD
Organizational Affiliation
William Osler Health Service Brampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Osler Health Service Brampton
City
Brampton
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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