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

NCT04001010 | Suspended Phase 3 DMC

• 1 other identifier: PPP011-Ph3-01
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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

Conditions

Cannabis Use; Cachexia; Cancer; Advanced Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• pain will be recorded: VAS

  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

  Observed and change from baseline in patient nutritional and functional assessment (PG-SGA) at baseline and week 4, 8 and, 12.

Study Arms (2)

inhaled THC/CBD (PPP011)

EXPERIMENTAL

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

Drug: PPP011

Placebo

PLACEBO COMPARATOR

Placebo inhalation with mighty medic device

Drug: Placebo

Interventions

PPP011 DRUG

1 capsule inhaled 3 times a day with a vaporizer device

Also known as: CAUMZ

inhaled THC/CBD (PPP011)

Placebo DRUG

1 capsule inhaled 3 times a day with a vaporizer device

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Tetra Bio-Pharma: lead

Study Sites (1)

William Osler Health Service Brampton

Brampton, Ontario, Canada

Location

MeSH Terms

Conditions

Cachexia; Neoplasms

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Martin Chasen, MD

  William Osler Health Service Brampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 27, 2019
• Study Start: July 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

CA (1)