The Effect of Medical Cannabis Inpatients With Palliative Pancreatic Cancer
| Registry | NCT03245658 |
|---|
| Status | Withdrawn - Organization was changed. The staff was relocated. |
|---|
| Phase | Phase 2 |
|---|
| Study type | Interventional; randomized, crossover, masking: none, treatment |
|---|
| Sponsor | Jens Rikardt Andersen (Other) |
|---|
| Conditions | Neoplasms Pancreatic, Cachexia; Cancer, Cannabis, Appetite Loss, Palliative Medicine, Morbidity, Mortality |
|---|
| Interventions | THC and CBD Mixture (Drug) |
|---|
| Dates | start 2017-10-06 (estimated), primary completion 2018-05-06 (estimated), completion 2018-10-06 (estimated), first posted 2017-08-10, last updated 2023-12-18 |
|---|
| Locations | 1 site in Denmark |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Neoplasms Pancreatic All trials for Cachexia; Cancer All trials of THC and CBD Mixture
-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.
Expand all sections · Collapse all
+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| THC and CBD Mixture | Experimental | Drug: 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 |
| Control | No intervention | | 32 patients with palliative pancreatic cancer, no experimental treatment, |
- THC and CBD Mixture (Drug), also known as Medical cannabis oral drops: Individually titrated doses on daily basis
+Outcome measures
Primary outcomes
- Energy and protein intake [The outcome measure will be assessed at day 0 and at week 4]: Dietary history (% of estimated needs - NRS 2002)
Secondary outcomes
- Lean body mass [The outcome measure will be assessed at day 0 and at week 4]: Bioimpedance (% of body weight, kg)
- Appetite 1 [The outcome measure will be assessed at day 0 and at week 4]: VAS (cm on 10 cm scale)
- Appetite 2 [The outcome measure will be assessed at day 0 and at week 4]: Dietary history (VAS (cm on 10 cm scale))
- Appetite 3 [The outcome measure will be assessed at day 0 and at week 4]: EORTC QLQ-C30 (score, standard for the Quality of Life entity)
- Appetite 4 [The outcome measure will be assessed at day 0 and at week 4]: EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
- Quality of life 1 [The outcome measure will be assessed at day 0 and at week 4]: EORTC QLQ-C30 (score, standard for the Quality of Life entity)
- Quality of life 2 [The outcome measure will be assessed at day 0 and at week 4]: EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
- Quality of life 3 [The outcome measure will be assessed at day 0 and at week 4]: VAS (VAS (cm on 10 cm scale))
- Pain 1 [The outcome measure will be assessed at day 0 and at week 4]: EORTC QLQ-C30 (score, standard for the Quality of Life entity)
- Pain 2 [The outcome measure will be assessed at day 0 and at week 4]: EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
- Pain 3 [The outcome measure will be assessed at day 0 and at week 4]: VAS (VAS (cm on 10 cm scale))
- Mortality (8 weeks) [8 weeks]: Patient records, national register
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Department of clinical oncology, Næstved-Roskilde Hospital | Næstved | Denmark | |
+Publications
- Results publication: Perras C. Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. 2005 Sep;(72):1-4. PMID 16317825
- Results publication: 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. PMID 27403414
- Results publication: 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. PMID 18728826
- Results publication: Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003. PMID 12648025
- Results publication: 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. PMID 17566383
- Results publication: 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. PMID 23141881
- Results publication: 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. PMID 19896326
- Results publication: 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. PMID 26883879
- Results publication: 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. PMID 22076835
- Results publication: 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. PMID 19587829
- Results publication: 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. PMID 19883531
- Results publication: 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. PMID 20076976
+Investigators