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Organization was changed. The staff was relocated.
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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.
Randomization of consecutive patients who wanted to participate to a daily dose of CBD or not as a supplement to the standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THC and CBD Mixture | Experimental | 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, |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THC and CBD Mixture | Drug | Individually titrated doses on daily basis |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Rikardt Andersen, MD, MPA | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of clinical oncology, Næstved-Roskilde Hospital | Næstved | 4700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16317825 | Result | Perras C. Sativex for the management of multiple sclerosis symptoms. Issues Emerg Health Technol. 2005 Sep;(72):1-4. | |
| 27403414 | Result | 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. |
| Label | URL |
|---|---|
| review | View source |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D002100 | Cachexia |
| D009369 | Neoplasms |
| D002189 | Marijuana Abuse |
| D000855 | Anorexia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
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| 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 |
| 18728826 | Result | 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. |
| 12648025 | Result | Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003. |
| 17566383 | Result | 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. |
| 23141881 | Result | 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. |
| 19896326 | Result | 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. |
| 26883879 | Result | 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. |
| 22076835 | Result | 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. |
| 19587829 | Result | 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. |
| 19883531 | Result | 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. |
| 20076976 | Result | 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. |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012817 | Signs and Symptoms, Digestive |