Clinical trial NCT03245658: The Effect of Cannabis in Pancreatic Cancer
Official title: The Effect of Medical Cannabis Inpatients With Palliative Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Neoplasms Pancreatic
Cachexia; Cancer
Cannabis
Appetite Loss
Palliative Medicine
Morbidity
Mortality
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Energy and protein intake
timeFrame: The outcome measure will be assessed at day 0 and at week 4
Secondary outcomes:
measure: Lean body mass
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Appetite 1
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Appetite 2
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Appetite 3
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Appetite 4
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Quality of life 1
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Quality of life 2
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Quality of life 3
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Pain 1
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Pain 2
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Pain 3
timeFrame: The outcome measure will be assessed at day 0 and at week 4
measure: Mortality (8 weeks)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Department of clinical oncology, Næstved-Roskilde Hospital
Study officials:
affiliation: University of Copenhagen
name: Jens Rikardt Andersen, MD, MPA
role: PRINCIPAL_INVESTIGATOR
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