The Effect of Cannabis in Pancreatic Cancer

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

Official Title
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The Effect of Medical Cannabis Inpatients With Palliative Pancreatic Cancer

Conditions
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Neoplasms Pancreatic, Cachexia; Cancer, Cannabis, Appetite Loss, Palliative Medicine, Morbidity, Mortality

Intervention / Treatment
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* Drug: THC and CBD Mixture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: THC and CBD Mixture<br>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<br>* Individually titrated doses on daily basis<br>* Other names: Medical cannabis oral drops;|
| No Intervention: Control<br>32 patients with palliative pancreatic cancer, no experimental treatment, | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass | Bioimpedance (% of body weight, kg) | The outcome measure will be assessed at day 0 and at week 4 | 
| Appetite 1 | VAS (cm on 10 cm scale) | The outcome measure will be assessed at day 0 and at week 4 | 
| Appetite 2 | Dietary history (VAS (cm on 10 cm scale)) | The outcome measure will be assessed at day 0 and at week 4 | 
| Appetite 3 | 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 | 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 | 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 | 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 | VAS (VAS (cm on 10 cm scale)) | The outcome measure will be assessed at day 0 and at week 4 | 
| Pain 1 | 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 | 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 | VAS (VAS (cm on 10 cm scale)) | The outcome measure will be assessed at day 0 and at week 4 | 
| Mortality (8 weeks) | Patient records, national register | 8 weeks |