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

TerminatedPhase 3NCT03339622
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

Brief summary (from the registry)

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.

Study details

Official title
Safety and Efficacy of PPP001-kit for Improving Health Related Quality of Life in Advanced Cancer Patients With Uncontrolled Pain: A Randomized, Double-blind, Placebo-Controlled, Parallel Group Study
Conditions
  • Cancer
  • Chronic Pain Due to Malignancy (Finding)
Interventions
  • Combination product: PPP001
  • Combination product: placebo
Sponsor
Tetra Bio-Pharma
Start date
2018-03-29
Primary completion
2018-12-17
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
Canada
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Written informed consent 2. Adult male and female patients at least 18 years of age 3. Subject agreed to follow the protocol 4. Advanced cancer for which there is no known curative therapy 5. Patients experiencing pain ≥4 on NRS due to cancer related pain 6. Life expectancy six weeks or longer 7. PPI score less than or equal to 4 (survival more than 6 weeks) 8. PPS greater than or equal 70% 9. PaP Score Group A (30-day survival probability \>70%) 10. An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 11. The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment 12. The patient is using no more than one type of breakthrough opioid analgesia 13. Normal cognitive status according to MDAS and MiniCog 14. Normal liver function (defined as aspartate aminotransferase 10-40 U/L and alanine aminotransferase 7-56 U/L) 15. Normal renal function (defined as serum creatinine level \<133 µmol/L and Estimated Glomerular Filtration Rate (eGFR) greater than or equal to 60) 16. The patient is able to perform deep inhalations and hold breath for at least 5 to 10 seconds. If there is any pulmonary disease diagnosed previously (obstructive and/or restrictive pathology), the patient must be able to perform a maximal inhalation of at least 12-15 ml/kg measured with an incentive spirometer, followed by a normal exhalation 17. Ability to read and respond to questions in French or English. 18. Previous or current use of opioid analgesics (at least 1 week) 19. 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. An acceptable method of contraception includes one of the following: * Abstinence from heterosexual intercourse * Systemic contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch) * Intrauterine device (with or without hormones) * Condom with spermicide or condom with intravaginally applied spermicide If of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least one year without menses) 20. A male volunteer with sexual partners who are pregnant, possibly pre…

Canadian sites (1)

FacilityCityProvince
Sante CannabisMontrealQuebec

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03339622