- anorexia [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
Lack of desire to eat food. Will be obtained through a questionnaire Anorexia / Cachexia scale from Functional Assessment of Anorexia Cachexia Therapy (FAACT) (score ≤24 diagnosis of anorexia)
- percentage weight loss [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
percentage weight loss in the last month
- Body Mass Index [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
It is an index of a person’s weight in relation to height
- Subjective Global Assessment [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
convenient, fast and cheaper method used to make a nutritional assessment, consisting of 3 parts: anamnesis, physical examination and qualification.
- energy consumption [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
Total calories consumed on average per day for a subject
- protein consumption [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
Total protein grams consumed on average per day for a subject
- lipids consumption [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
Total lipids grams consumed on average per day for a subject
- carbohydrate consumption [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
Total carbohydrate grams consumed on average per day for a subject
- nausea [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
adverse effect from Common terminology criteria for adverse event
- vomiting [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
adverse effect from Common terminology criteria for adverse event
- constipation [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
adverse effect from Common terminology criteria for adverse event
- Diarrhea [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
adverse effect from Common terminology criteria for adverse event
- Dysgeusia [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
adverse effect from Common terminology criteria for adverse event
- Global Status of Quality of Life [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The Global status of Quality of Life evaluation is evaluated using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer with the items 29 and 30.
- Physical functioning [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The Physical functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer
- Role Functioning [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The Role functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer
- Emotional Functioning [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The Emotional Functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer
- Social Functioning [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The Social Functioning evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer
- Nausea/Vomiting [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The Nausea/Vomiting evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer
- Fatigue [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The Fatigue evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer
- appetite loss [ Time Frame: from the start of consumption until 8 weeks. ] [ Designated as safety issue: Yes ]
The appetite loss evaluation is evaluated from the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer
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 (A/CS-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 A/CS-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 III/IV NSCLC, ECOG performance status (ECOG PS) 1-2 and anorexia (main criteria: score of Anorexia Cachexia scale (AC/S-12) from Functional Assessment of Anorexia Cachexia Therapy ≤24). Patients are randomized to Nabilone at 0.5mg 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 0.5mg 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, 2.5 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 0.05