Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients

NCT03339622 | Terminated Phase 3 DMC

• 1 other identifier: PPP001-Ph3-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer causes pain in many of the patients that it affects. Physicians specialized in palliative care help advanced cancer patients to maintain as good pain control as possible through the use of medications such as opioids. Even with palliative care and optimal use of medications, many patients still suffer enormously as the cancer spreads. Because of this, some cancer patients also try or use cannabis in different ways to relieve their pain and improve the way they feel. However, there has not been much high-quality research done yet to prove whether or not cannabis products are truly useful to relieve severe cancer pain. This study is to test if advanced cancer patients who use inhaled medical cannabis (PPP001), in addition to palliative care management, will experience improvement in quality of life and relieve uncontrolled pain, providing safety conditions.

Conditions

Cancer; Chronic Pain Due to Malignancy (Finding)

Keywords

uncontrollable cancer pain; incurable malignancy,

Outcome Measures

Primary Outcomes (1)

• improve Health Related Quality of Life (HRQoL) of patients with uncontrolled cancer pain and incurable malignancy

  Does the daily use of PPP001-kit improve European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 15 Palliative (EORTC-QLQ-C15-PAL). Scale range is 1 to 4; 1 (Not at All) being the worst rating to the maximal rating of 4 (Very Much).

  Change from Baseline in HRQoL at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months.

Secondary Outcomes (12)

• Does the daily use of PPP001-kit improve uncontrolled cancer pain

  Change from Baseline in BPI-SF at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months

• Does the daily use of PPP001-kit improve symptom burden

  Change from Baseline in ESAS-r-CS at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months

• Does the daily use of PPP001-kit improve functional status

  Change from Baseline in PPSv2 at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months

• Does the daily use of PPP001-kit improve the QoL of family caregivers

  Change from Baseline in CQOLC at Weeks 1 and 4

• Changes in validated Udvalg for klinische Undersøgelser (UKU) Side Effects Rating Scale, Self-rating version for Patients (UKU-SERS-Pat)

  Change versus placebo for safety and tolerability at Weeks 1 and 4. Change from baseline at 12-weeks follow-up and every 6-weeks after week 12 follow-up until the date of death from any cause or assessed up to 12 months.

Study Arms (2)

smoked cannabis (PPP001)

EXPERIMENTAL

280 mg dried cannabis pellet -(9% THC / 2% CBD per pellet)

Combination Product: PPP001

THC free placebo

PLACEBO COMPARATOR

280 mg dried extracted cannabis pellet (0% THC / 0.6% CBD per pellet)

Combination Product: placebo

Interventions

PPP001 COMBINATION_PRODUCT

1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)

Also known as: titanium pipe

smoked cannabis (PPP001)

placebo COMBINATION_PRODUCT

1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)

Also known as: titanium pipe

THC free 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
• Subject agreed to follow the protocol
• Advanced cancer for which there is no known curative therapy
• Patients experiencing pain ≥4 on NRS due to cancer related pain
• Life expectancy six weeks or longer
• PPI score less than or equal to 4 (survival more than 6 weeks)
• PPS greater than or equal 70%
• PaP Score Group A (30-day survival probability \>70%)
• An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
• The patient is using no more than one type of breakthrough opioid analgesia
• Normal cognitive status according to MDAS and MiniCog
• Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L)
• Normal renal function (defined as serum creatinine level \<133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60)

You may not qualify if:

• Pain due to other causes different than cancer related pain
• Previous serious adverse event or hypersensitivity to cannabis or cannabinoids
• Inability to understand and comply with the instructions of the study
• Presence of significant cardiac disease (history of unstable ischemic heart disease, heart failure, severe and uncontrolled hypertension) that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
• Current substance use disorder according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM 5)
• Life-time history of dependence on cannabis or diagnosis of cannabis use disorder (CUD) according to the DSM 5
• Life-time history of DSM 5 schizophrenia, bipolar disorder, or previous psychosis with or intolerance to cannabinoids
• Current or history of suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS) approved by FDA in 2012 for assessment of suicidal ideation and behaviour
• Pregnant, breast-feeding or female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)
• Hepatic impairment (aspartate aminotransferase more than three times normal) or renal function impairment (serum creatinine level \>133 µmol/L, Estimated Glomerular Filtration Rate (eGFR) \<60)
• Cognitive impairment according to MDAS and MiniCog
• Patient has any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
• Cancer treatments that may interfere with stability of treatment (epidural, radiotherapy, chemotherapy, hormonal therapy)
• Epilepsy
• The patient is currently using or has used cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study

Sponsors & Collaborators

• Tetra Bio-Pharma: lead

Study Sites (1)

Sante Cannabis

Montreal, Quebec, H2L 3K9, Canada

Location

MeSH Terms

Conditions

Neoplasms; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Vigano, MD, MSc

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 13, 2017
• Study Start: March 29, 2018
• Primary Completion: December 17, 2018
• Study Completion: February 8, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

CA (1)