Ignite Creation Date:
2024-05-06 @ 8:42 AM
Last Modification Date:
2024-10-26 @ 12:04 PM
Study NCT ID:
NCT02802540
Status:
UNKNOWN
Last Update Posted:
2016-08-31
First Post:
2016-05-22
Brief Title:
Nabilone Effect on the Attenuation of Anorexia Nutritional Status and Quality of Life in Lung Cancer Patients
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
Nabilone Effect on the Attenuation of Anorexia Nutritional Status and Quality of Life in Patients With Anorexia Associated With Advanced Lung Cancer Randomized Double Blind Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Anorexia is common symptom in cancer patients and is associated with increased morbidity and mortality However timely detection with objective tools is necessary to establish the diagnosis of anorexia and to assess the magnitude of change over time The anorexia pathophysiology is not clearly understood and treatment options are limited Anecdotal historical benefits of smoking marijuana on nausea pain and anorexia led to studies with marijuana and synthetic cannabinoids from Δ-9-tetrahydrocannabinol the main active agent in marijuana The endogenous cannabinoid system with its receptors CB1 and CB2 regulate appetite in four functional levels 1 limbic system hedonistic quality 2 hypothalamus appetite stimulant 3 intestinal and 4 tissue adipose
Nabilone a synthetic analogue of THC approved in Mexico for nausea and vomiting induced by chemotherapy is also used in palliative care units for clinical improvement in increased appetite patients in terminal stages however there are no clinical trials demonstrating this benefit
Nabilone a synthetic analogue of THC approved in Mexico for nausea and vomiting induced by chemotherapy is also used in palliative care units for clinical improvement in increased appetite patients in terminal stages however there are no clinical trials demonstrating this benefit
Detailed Description:
Background Lung cancer is the leading cause of cancer death in Mexico and the world Malnutrition is often associated with this type of cancer appearing in about 40-50 of patients the diagnosis made affecting the quality of life and prognosis as well as increased toxicity to cancer treatment Cancer anorexia is characterized by loss of appetite and is the main cause of reduced food consumption in lung cancer patients Anorexia occurs in up to 25 of cases Unfortunately current therapies available to treat anorexia and or cachexia associated with cancer provide only partial results mainly because the intervention is delayed and the development of an early and effective intervention is still looking
In most patients malnutrition is associated with a hyporexia secondary to the production of pro-inflammatory cytokines such as tumor necrosis factor TNF leading to an increase in metabolism and appetite loss Nabilone is a synthetic cannabinoid derivative that is widely used in oncology for its antiemetic and adjuvant effect of pain Although widely used for the treatment of anorexia in palliative care no randomized clinical trials demonstrating an effect on cancer-associated anorexia however in animal models stimulation of cannabinoid receptors mainly through CB1 receptor can modulate hypothalamic circuits in the brain stem which in turn regulate food intake and satiety Moreover cannabinoids are able to block the effects of TNF in the nervous system which is associated with appetite changes in cancer patients Additionally agonists of cannabinoid receptors attenuated weight loss in murine models of anorexia
Additionally to diagnosis anorexia The Anorexia-Cachexia scale ACS-12 from The Functional Assessment of Anorexia-Cachexia therapy FAACT questionnaire relates differences in symptoms and severity assigning a value of 0-4 for each of 12 items A 2010 consensus of special interest group of CACS from ESPEN The European Society for Clinical Nutrition and Metabolism in order to unify criteria proposed that a score 24 of the ACS-12 would be enough to establish a diagnosis of anorexia
The administration of Nabilone in patients with anorexia associated with Non-Small Cell Lung Cancer NSCLC is expected to increase appetite nutritional status and quality of life
Methods randomized double-blind clinical trial assessing Nabilone effect in non-small cell lung cancer NSCLC patients with unresectable stage IIIIV NSCLC ECOG performance status ECOG PS 1-2 and anorexia main criteria score of Anorexia Cachexia scale ACS-12 from Functional Assessment of Anorexia Cachexia Therapy 24 Patients are randomized to Nabilone at 05mg to 1mg or placebo given daily orally for 8 weeks Changes are evaluated from baseline to week 2 4 and 8
Time Assessment Dose T0 Baseline 05mg T1 2 weeks 1 mg T2 4 weeks 1 mg T3 8 weeks 1 mg
Sample size
To determine the sample size is considered the effect of cannabinoid dronabinol 25 mg 22 days in appetite in cancer patients by a difference in proportions of 34 more than placebo requiring 32 patients per group plus 20 of loss gives us a total of 39 patients per group with a power of 90 and an α of 005
In most patients malnutrition is associated with a hyporexia secondary to the production of pro-inflammatory cytokines such as tumor necrosis factor TNF leading to an increase in metabolism and appetite loss Nabilone is a synthetic cannabinoid derivative that is widely used in oncology for its antiemetic and adjuvant effect of pain Although widely used for the treatment of anorexia in palliative care no randomized clinical trials demonstrating an effect on cancer-associated anorexia however in animal models stimulation of cannabinoid receptors mainly through CB1 receptor can modulate hypothalamic circuits in the brain stem which in turn regulate food intake and satiety Moreover cannabinoids are able to block the effects of TNF in the nervous system which is associated with appetite changes in cancer patients Additionally agonists of cannabinoid receptors attenuated weight loss in murine models of anorexia
Additionally to diagnosis anorexia The Anorexia-Cachexia scale ACS-12 from The Functional Assessment of Anorexia-Cachexia therapy FAACT questionnaire relates differences in symptoms and severity assigning a value of 0-4 for each of 12 items A 2010 consensus of special interest group of CACS from ESPEN The European Society for Clinical Nutrition and Metabolism in order to unify criteria proposed that a score 24 of the ACS-12 would be enough to establish a diagnosis of anorexia
The administration of Nabilone in patients with anorexia associated with Non-Small Cell Lung Cancer NSCLC is expected to increase appetite nutritional status and quality of life
Methods randomized double-blind clinical trial assessing Nabilone effect in non-small cell lung cancer NSCLC patients with unresectable stage IIIIV NSCLC ECOG performance status ECOG PS 1-2 and anorexia main criteria score of Anorexia Cachexia scale ACS-12 from Functional Assessment of Anorexia Cachexia Therapy 24 Patients are randomized to Nabilone at 05mg to 1mg or placebo given daily orally for 8 weeks Changes are evaluated from baseline to week 2 4 and 8
Time Assessment Dose T0 Baseline 05mg T1 2 weeks 1 mg T2 4 weeks 1 mg T3 8 weeks 1 mg
Sample size
To determine the sample size is considered the effect of cannabinoid dronabinol 25 mg 22 days in appetite in cancer patients by a difference in proportions of 34 more than placebo requiring 32 patients per group plus 20 of loss gives us a total of 39 patients per group with a power of 90 and an α of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None