The Effect of Cannabis in Pancreatic Cancer

Mortality Clinical Trial

Official title:

The Effect of Medical Cannabis Inpatients With Palliative Pancreatic Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03245658
• Other study ID #: H-17000277
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 6, 2017
• Est. completion date: October 6, 2018

Study information

• Verified date: December 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 6, 2018
• Est. primary completion date: May 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appetite Loss
• Cachexia
• Cachexia; Cancer
• Cannabis
• Marijuana Abuse
• Morbidity
• Mortality
• Neoplasms Pancreatic
• Palliative Medicine

Intervention

Drug:
• THC and CBD Mixture
Individually titrated doses on daily basis

Locations

Country	Name	City	State
Denmark	Department of clinical oncology, Næstved-Roskilde Hospital	Naestved

Sponsors (1)

Lead Sponsor	Collaborator
Jens Rikardt Andersen

Country where clinical trial is conducted

Denmark, 

References & Publications (12)

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: 10.10 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003. — View Citation

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. — View Citation

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 in — View Citation

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 stron — View Citation

Perras C. Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. 2005 Sep;(72):1-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy and protein intake	Dietary history (% of estimated needs - NRS 2002)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Lean body mass	Bioimpedance (% of body weight, kg)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Appetite 1	VAS (cm on 10 cm scale)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Appetite 2	Dietary history (VAS (cm on 10 cm scale))	The outcome measure will be assessed at day 0 and at week 4
Secondary	Appetite 3	EORTC QLQ-C30 (score, standard for the Quality of Life entity)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Appetite 4	EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Quality of life 1	EORTC QLQ-C30 (score, standard for the Quality of Life entity)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Quality of life 2	EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Quality of life 3	VAS (VAS (cm on 10 cm scale))	The outcome measure will be assessed at day 0 and at week 4
Secondary	Pain 1	EORTC QLQ-C30 (score, standard for the Quality of Life entity)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Pain 2	EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)	The outcome measure will be assessed at day 0 and at week 4
Secondary	Pain 3	VAS (VAS (cm on 10 cm scale))	The outcome measure will be assessed at day 0 and at week 4
Secondary	Mortality (8 weeks)	Patient records, national register	8 weeks

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