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2017-10-06
2018-05-06
2018-10-06
0
NCT03245658
University of Copenhagen
University of Copenhagen
INTERVENTIONAL
The Effect of Cannabis in 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.
Randomization of consecutive patients who wanted to participate to a daily dose of CBD or not as a supplement to the standard treatment.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-03-21 | N/A | 2023-12-11 |
2017-08-09 | N/A | 2023-12-18 |
2017-08-10 | N/A | 2023-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
None
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
|
| NO_INTERVENTION: Control 32 patients with palliative pancreatic cancer, no experimental treatment, |
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
