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)

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

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

Study Overview

• Status: Suspended
• Conditions: Advanced Cancer; Cannabis Use; Cachexia; Cancer
• Intervention / Treatment: Drug: PPP011; Drug: Placebo

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: Interventional
• Enrollment (Anticipated): 334
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada
      • William Osler Health Service Brampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: CAUMZ
PLACEBO_COMPARATOR: Placebo; Placebo inhalation with mighty medic device	Drug: Placebo; 1 capsule inhaled 3 times a day with a vaporizer device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline in EORTC-QLQ-C15-PAL physical functioning in multi-item scales at week 4, 8 and 12 W4 W8 W12
Cachexia grade will be measured as per Weight Loss Grading System	Downgrading cachexia grade or grade maintenance will be considered as a drug benefit.	Change from baseline at week 4, 8 and 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain will be recorded: VAS	using a visual analogue scale. horizontal 0-100 mm VAS assessing pain	Observed and Change from baseline in a VAS on pain AND no increase in pain medications at week 4, 8 and, 12 and 24.
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	Observed and change from baseline in patient nutritional and functional assessment (PG-SGA) at baseline and week 4, 8 and, 12.

Collaborators and Investigators

• Sponsor: Tetra Bio-Pharma
• Investigators: Principal Investigator: Martin Chasen, MD, William Osler Health Service Brampton

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (ACTUAL): June 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Neoplasms; Wasting Syndrome; Cachexia
• Other Study ID Numbers: PPP011-Ph3-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No