NCT03245658

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2018

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

March 21, 2017

Last Update Submit

December 11, 2023

Conditions

Neoplasms PancreaticCachexia; CancerCannabisAppetite LossPalliative MedicineMorbidityMortality

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Lean body mass

    The outcome measure will be assessed at day 0 and at week 4

  • Appetite 1

    The outcome measure will be assessed at day 0 and at week 4

  • Appetite 2

    The outcome measure will be assessed at day 0 and at week 4

  • Appetite 3

    The outcome measure will be assessed at day 0 and at week 4

  • Appetite 4

    The outcome measure will be assessed at day 0 and at week 4

  • +7 more secondary outcomes

Study Arms (2)

THC and CBD Mixture

EXPERIMENTAL

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

Control

NO INTERVENTION

32 patients with palliative pancreatic cancer, no experimental treatment,

Interventions

THC and CBD MixtureDRUG

Individually titrated doses on daily basis

Also known as: Medical cannabis oral drops
THC and CBD Mixture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of clinical oncology, Næstved-Roskilde Hospital

Næstved, 4700, Denmark

Location

Related Publications (12)

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

    PMID: 16317825RESULT

  • 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.

    PMID: 27403414RESULT

  • 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.

    PMID: 18728826RESULT

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

    PMID: 12648025RESULT

  • 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.

    PMID: 17566383RESULT

  • 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.

    PMID: 23141881RESULT

  • 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.

    PMID: 19896326RESULT

  • 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.

    PMID: 26883879RESULT

  • 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.

    PMID: 22076835RESULT

  • 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.

    PMID: 19587829RESULT

  • 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.

    PMID: 19883531RESULT

  • 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.

    PMID: 20076976RESULT

Related Links

MeSH Terms

Conditions

Pancreatic NeoplasmsCachexiaNeoplasmsMarijuana AbuseAnorexia

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesWeight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessSubstance-Related DisordersChemically-Induced DisordersMental DisordersSigns and Symptoms, Digestive

Study Officials

  • Jens Rikardt Andersen, MD, MPA

    University of Copenhagen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2017

First Posted

August 10, 2017

Study Start

October 6, 2017

Primary Completion

May 6, 2018

Study Completion

October 6, 2018

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)