ClinicalTrials.gg
WithdrawnNCT03245658Updated Dec 18, 2023

The Effect of Cannabis in Pancreatic Cancer

A Phase 2 interventional study of THC and CBD Mixture in Neoplasms Pancreatic, Cachexia; Cancer and Cannabis, sponsored by Jens Rikardt Andersen. Withdrawn at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Jens Rikardt Andersen · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Organization was changed. The staff was relocated.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Neoplasms Pancreatic
  • Cachexia; Cancer
  • Cannabis
  • Appetite Loss
  • Palliative Medicine
  • Morbidity
  • Mortality
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Jens Rikardt Andersen is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Regular use of cannabis, psychiatric disorders, alcohol abuse, \< 6 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • No intervention
    Control

    32 patients with palliative pancreatic cancer, no experimental treatment,

Interventions

  • DrugTHC and CBD Mixture

    Drug page: Nabiximols

    Individually titrated doses on daily basis

    Also known as: Medical cannabis oral drops

06

What researchers measure

Primary outcomes

  1. Energy and protein intake

    Dietary history (% of estimated needs - NRS 2002)

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

Secondary outcomes

  1. Lean body mass

    Bioimpedance (% of body weight, kg)

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

  2. Appetite 1

    VAS (cm on 10 cm scale)

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

  3. Appetite 2

    Dietary history (VAS (cm on 10 cm scale))

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

  4. Appetite 3

    EORTC QLQ-C30 (score, standard for the Quality of Life entity)

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

  5. Appetite 4

    EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)

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

  6. Quality of life 1

    EORTC QLQ-C30 (score, standard for the Quality of Life entity)

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

  7. Quality of life 2

    EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)

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

  8. Quality of life 3

    VAS (VAS (cm on 10 cm scale))

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

  9. Pain 1

    EORTC QLQ-C30 (score, standard for the Quality of Life entity)

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

  10. Pain 2

    EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)

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

  11. Pain 3

    VAS (VAS (cm on 10 cm scale))

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

  12. Mortality (8 weeks)

    Patient records, national register

    Time frame: 8 weeks

07

Study locations

1 site
  • Department of clinical oncology, Næstved-Roskilde Hospital
    Naestved, 4700, Denmark
08

References and documents

Publications

  • Perras C. Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. 2005 Sep;(72):1-4. PubMed 16317825 ↗
  • 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. PubMed 27403414 ↗
  • 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. PubMed 18728826 ↗
  • Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003. PubMed 12648025 ↗
  • 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. PubMed 17566383 ↗
  • 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. PubMed 23141881 ↗
  • 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. PubMed 19896326 ↗
  • 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. PubMed 26883879 ↗
  • 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. PubMed 22076835 ↗
  • 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. PubMed 19587829 ↗
  • 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. PubMed 19883531 ↗
  • 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. PubMed 20076976 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03245658
Lead sponsor
Jens Rikardt Andersen
Responsible party
Jens Rikardt Andersen (Associate Professor, University of Copenhagen) — Sponsor-investigator
First posted
Aug 10, 2017
Start date
Oct 6, 2017 (estimated)
Primary completion
May 6, 2018 (estimated)
Completion
Oct 6, 2018 (estimated)
Last update
Dec 18, 2023

Study contacts

Jens Rikardt Andersen, MD, MPA
principal investigator · University of Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Nabiximols

Start the discussion