The Effect of Cannabis in Pancreatic Cancer

December 11, 2023 updated by: Jens Rikardt Andersen

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Individually titrated doses on daily basis
Other Names:
  • Medical cannabis oral drops
No Intervention: Control
32 patients with palliative pancreatic cancer, no experimental treatment,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy and protein intake
Time Frame: The outcome measure will be assessed at day 0 and at week 4
Dietary history (% of estimated needs - NRS 2002)
The outcome measure will be assessed at day 0 and at week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lean body mass
Time Frame: The outcome measure will be assessed at day 0 and at week 4
Bioimpedance (% of body weight, kg)
The outcome measure will be assessed at day 0 and at week 4
Appetite 1
Time Frame: The outcome measure will be assessed at day 0 and at week 4
VAS (cm on 10 cm scale)
The outcome measure will be assessed at day 0 and at week 4
Appetite 2
Time Frame: The outcome measure will be assessed at day 0 and at week 4
Dietary history (VAS (cm on 10 cm scale))
The outcome measure will be assessed at day 0 and at week 4
Appetite 3
Time Frame: The outcome measure will be assessed at day 0 and at week 4
EORTC QLQ-C30 (score, standard for the Quality of Life entity)
The outcome measure will be assessed at day 0 and at week 4
Appetite 4
Time Frame: The outcome measure will be assessed at day 0 and at week 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
Quality of life 1
Time Frame: The outcome measure will be assessed at day 0 and at week 4
EORTC QLQ-C30 (score, standard for the Quality of Life entity)
The outcome measure will be assessed at day 0 and at week 4
Quality of life 2
Time Frame: The outcome measure will be assessed at day 0 and at week 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
Quality of life 3
Time Frame: The outcome measure will be assessed at day 0 and at week 4
VAS (VAS (cm on 10 cm scale))
The outcome measure will be assessed at day 0 and at week 4
Pain 1
Time Frame: The outcome measure will be assessed at day 0 and at week 4
EORTC QLQ-C30 (score, standard for the Quality of Life entity)
The outcome measure will be assessed at day 0 and at week 4
Pain 2
Time Frame: The outcome measure will be assessed at day 0 and at week 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
Pain 3
Time Frame: The outcome measure will be assessed at day 0 and at week 4
VAS (VAS (cm on 10 cm scale))
The outcome measure will be assessed at day 0 and at week 4
Mortality (8 weeks)
Time Frame: 8 weeks
Patient records, national register
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jens Rikardt Andersen

Collaborators

Augustinus Fonden
Københavns Universitet
Familien Hede Nielsens Fond

Investigators

  • Principal Investigator: Jens Rikardt Andersen, MD, MPA, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 6, 2017

Primary Completion (Estimated)

May 6, 2018

Study Completion (Estimated)

October 6, 2018

Study Registration Dates

First Submitted

March 21, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17000277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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