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)

Tetra Bio-Pharma

Status and phase: Suspended; Phase 3

Conditions: Advanced Cancer; Cannabis Use; Cachexia; Cancer

Treatments: Drug: Placebo; Drug: PPP011

Study type: Interventional

Funder types: Industry

Identifiers

NCT04001010

PPP011-Ph3-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 334 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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334 participants in 2 patient groups, including a placebo group

inhaled THC/CBD (PPP011)

Experimental group

Description:

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

Treatment:

Drug: PPP011

Placebo

Placebo Comparator group

Description:

Placebo inhalation with mighty medic device

Treatment:

Drug: Placebo