AzTrials
AzTrials

Neoplasms PancreaticPhase 2NCT03245658

The Effect of Cannabis in Pancreatic Cancer

A Phase 2 study testing THC and CBD Mixture in people with Neoplasms Pancreatic and Cachexia; Cancer, run by Jens Rikardt Andersen at 1 site in Denmark.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms Pancreatic, Cachexia; Cancer, Cannabis
What is being tested?
THC and CBD Mixture
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteDenmark
Study dates
6 Oct 2017to 6 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of clinical oncology, Næstved-Roskilde Hospital

    Næstved, 4700

Other trials in Denmark

About this study

Official title: The Effect of Medical Cannabis Inpatients With Palliative 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.

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.

Being tested
THC and CBD Mixture
Medical subject headings
Pancreatic Neoplasms, Cachexia, Neoplasms, Marijuana Abuse, Anorexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THC and CBD MixtureDrug

    Also called Medical cannabis oral drops

    Individually titrated doses on daily basis

Study groups in NCT03245658
Study groupRoleWhat they receive
THC and CBD MixtureExperimental32 patients with palliative pancreatic cancer, intervention with oral drops of THC, 25mg/ml and CBD 50mg/ml, daily administered for 4 weeks
Receives: Drug: THC and CBD Mixture
ControlNo intervention32 patients with palliative pancreatic cancer, no experimental treatment,

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Energy and protein intake

    Dietary history (% of estimated needs - NRS 2002)

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

Secondary outcomes (12)

  1. Lean body mass

    Bioimpedance (% of body weight, kg)

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

  2. Appetite 1

    VAS (cm on 10 cm scale)

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

  3. Appetite 2

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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))

    Measured: 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)

    Measured: 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)

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

  11. Pain 3

    VAS (VAS (cm on 10 cm scale))

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

  12. Mortality (8 weeks)

    Patient records, national register

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2017
  2. Study start6 Oct 2017 (estimated)
  3. Primary completion6 May 2018 (estimated)
  4. Study completion6 Oct 2018 (estimated)

Why it stopped: Organization was changed. The staff was relocated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03245658
Sponsor's protocol ID
H-17000277
Status last verified
Dec 2023
First submitted
21 Mar 2017
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing THC and CBD Mixture in people with Neoplasms Pancreatic and Cachexia; Cancer, run by Jens Rikardt Andersen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Energy and protein intake (time frame: The outcome measure will be assessed at day 0 and at week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03245658, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.

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