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The Effect of Cannabis in Pancreatic Cancer


2017-10-06


2018-05-06


2018-10-06


0

Study Overview

The Effect of Cannabis in Pancreatic Cancer

Cannabinoids are known to increase appetite, but THC components have psychogenic properties too. CBD is the main component in the plant, and have only minimal psychogenic effects. The aim was to test the appetite stimulating effects of CBD in patients with pancreatic cancer in palliative treatment.

Randomization of consecutive patients who wanted to participate to a daily dose of CBD or not as a supplement to the standard treatment.

  • Neoplasms Pancreatic
  • Cachexia; Cancer
  • Cannabis
  • Appetite Loss
  • Palliative Medicine
  • Morbidity
  • Mortality
  • DRUG: THC and CBD Mixture
  • H-17000277

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2017-03-21  

N/A  

2023-12-11  

2017-08-09  

N/A  

2023-12-18  

2017-08-10  

N/A  

2023-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Randomized


Interventional Model:
Crossover


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: THC and CBD Mixture

32 patients with palliative pancreatic cancer, intervention with oral drops of THC, 25mg/ml and CBD 50mg/ml, daily administered for 4 weeks

DRUG: THC and CBD Mixture

  • Individually titrated doses on daily basis
NO_INTERVENTION: Control

32 patients with palliative pancreatic cancer, no experimental treatment,

Primary Outcome MeasuresMeasure DescriptionTime Frame
Energy and protein intakeDietary history (% of estimated needs - NRS 2002)The outcome measure will be assessed at day 0 and at week 4
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Lean body massBioimpedance (% of body weight, kg)The outcome measure will be assessed at day 0 and at week 4
Appetite 1VAS (cm on 10 cm scale)The outcome measure will be assessed at day 0 and at week 4
Appetite 2Dietary history (VAS (cm on 10 cm scale))The outcome measure will be assessed at day 0 and at week 4
Appetite 3EORTC QLQ-C30 (score, standard for the Quality of Life entity)The outcome measure will be assessed at day 0 and at week 4
Appetite 4EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)The outcome measure will be assessed at day 0 and at week 4
Quality of life 1EORTC QLQ-C30 (score, standard for the Quality of Life entity)The outcome measure will be assessed at day 0 and at week 4
Quality of life 2EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)The outcome measure will be assessed at day 0 and at week 4
Quality of life 3VAS (VAS (cm on 10 cm scale))The outcome measure will be assessed at day 0 and at week 4
Pain 1EORTC QLQ-C30 (score, standard for the Quality of Life entity)The outcome measure will be assessed at day 0 and at week 4
Pain 2EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)The outcome measure will be assessed at day 0 and at week 4
Pain 3VAS (VAS (cm on 10 cm scale))The outcome measure will be assessed at day 0 and at week 4
Mortality (8 weeks)Patient records, national register8 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • Adult, palliative pancreatic cancer diagnosis, weight loss > 5%, understand and read Danish.

  • Exclusion Criteria:

  • Regular use of cannabis, psychiatric disorders, alcohol abuse, life expectancy < 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Jens Rikardt Andersen, MD, MPA, University of Copenhagen

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Perras C. Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. 2005 Sep;(72):1-4.
    • Gartner S, Kruger J, Aghdassi AA, Steveling A, Simon P, Lerch MM, Mayerle J. Nutrition in Pancreatic Cancer: A Review. Gastrointest Tumors. 2016 May;2(4):195-202. doi: 10.1159/000442873. Epub 2016 Jan 8.
    • Ware MA, Daeninck P, Maida V. A review of nabilone in the treatment of chemotherapy-induced nausea and vomiting. Ther Clin Risk Manag. 2008 Feb;4(1):99-107. doi: 10.2147/tcrm.s1132.
    • Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
    • Slatkin NE. Cannabinoids in the treatment of chemotherapy-induced nausea and vomiting: beyond prevention of acute emesis. J Support Oncol. 2007 May;5(5 Suppl 3):1-9.
    • Johnson JR, Lossignol D, Burnell-Nugent M, Fallon MT. An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. J Pain Symptom Manage. 2013 Aug;46(2):207-18. doi: 10.1016/j.jpainsymman.2012.07.014. Epub 2012 Nov 8.
    • Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.
    • Reuter SE, Martin JH. Pharmacokinetics of Cannabis in Cancer Cachexia-Anorexia Syndrome. Clin Pharmacokinet. 2016 Jul;55(7):807-812. doi: 10.1007/s40262-015-0363-2.
    • Gamage TF, Lichtman AH. The endocannabinoid system: role in energy regulation. Pediatr Blood Cancer. 2012 Jan;58(1):144-8. doi: 10.1002/pbc.23367.
    • Fox KM, Brooks JM, Gandra SR, Markus R, Chiou CF. Estimation of Cachexia among Cancer Patients Based on Four Definitions. J Oncol. 2009;2009:693458. doi: 10.1155/2009/693458. Epub 2009 Jul 1.
    • Gullett N, Rossi P, Kucuk O, Johnstone PA. Cancer-induced cachexia: a guide for the oncologist. J Soc Integr Oncol. 2009 Fall;7(4):155-69.
    • Blum D, Omlin A, Fearon K, Baracos V, Radbruch L, Kaasa S, Strasser F; European Palliative Care Research Collaborative. Evolving classification systems for cancer cachexia: ready for clinical practice? Support Care Cancer. 2010 Mar;18(3):273-9. doi: 10.1007/s00520-009-0800-6.