The Effect of Cannabis in Pancreatic Cancer

NCT ID: NCT03245658

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-06

Study Completion Date

2018-10-06

Brief Summary

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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.

Detailed Description

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

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

THC and CBD Mixture

Intervention Type DRUG

Individually titrated doses on daily basis

Control

32 patients with palliative pancreatic cancer, no experimental treatment,

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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THC and CBD Mixture

Individually titrated doses on daily basis

Intervention Type DRUG

Other Intervention Names

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Medical cannabis oral drops

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jens Rikardt Andersen

OTHER

Sponsor Role lead

Responsible Party

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Jens Rikardt Andersen

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jens Rikardt Andersen, MD, MPA

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Department of clinical oncology, Næstved-Roskilde Hospital

Næstved, , Denmark

Site Status

Countries

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Denmark

References

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

Reference Type RESULT
PMID: 16317825 (View on PubMed)

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.

Reference Type RESULT
PMID: 27403414 (View on PubMed)

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.

Reference Type RESULT
PMID: 18728826 (View on PubMed)

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

Reference Type RESULT
PMID: 12648025 (View on PubMed)

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.

Reference Type RESULT
PMID: 17566383 (View on PubMed)

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.

Reference Type RESULT
PMID: 23141881 (View on PubMed)

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.

Reference Type RESULT
PMID: 19896326 (View on PubMed)

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.

Reference Type RESULT
PMID: 26883879 (View on PubMed)

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.

Reference Type RESULT
PMID: 22076835 (View on PubMed)

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.

Reference Type RESULT
PMID: 19587829 (View on PubMed)

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.

Reference Type RESULT
PMID: 19883531 (View on PubMed)

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.

Reference Type RESULT
PMID: 20076976 (View on PubMed)

Related Links

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Other Identifiers

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H-17000277

Identifier Type: -

Identifier Source: org_study_id