Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04748523
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2020-11-19
Brief Title:
Effect of Mirtazapine Versus Placebo in Patients With Non-small Cell Lung Cancer and Anorexia
Sponsor:
Instituto Nacional de Cancerologia de Mexico
Organization:
Instituto Nacional de Cancerologia de Mexico
Study Overview
Official Title:
Effect of Mirtazapine Versus Placebo on Appetite Nutritional Status and Quality of Life in Non-small Cell Lung cáncer Patients With Anorexia Randomized Double-blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
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:
The realization of this project will generate an important advance in knowledge regarding one of the most important comorbidities in cancer patients malnutrition
Currently comprehensive treatments of cancer patients recognize the importance of the assessment of nutritional status and the impact it has on the prognosis quality of life and toxicity generated by cancer treatment Due to this it is imperative to offer diagnostic tools that identify patients in a timely manner and in addition to this offer therapeutic strategies for the improvement of nutritional status in an adjuvant manner to their oncological treatment
It is widely recognized that the cachexia-anorexia syndrome CACS is present in 30 to 80 of cases in cancer patients and this proportion increases as the disease progresses with weight loss being a powerful predictor of shorter survival Unfortunately current therapies available to treat anorexia and or cancer-associated cachexia offer only partial results mainly because the intervention is late and the development of an earlier and more effective intervention is still sought Mirtazapine has recently gained attention not only because of its antidepressant effect but also because of its potential benefit in patients with anorexia and weight loss recently reported in a phase II study Therefore it is important to continue its evaluation through a randomized double-blind clinical trial in which the effect of mirtazapine is compared and it is determined if it is superior compared to placebo to increase appetite in patients with NSCLC who present with anorexia
This type of strategy is a relevant therapeutic option in those patients in whom nutritional counseling by itself is not sufficient to counteract the damage caused by anorexia and to cope with or prevent the development of cachexia
Currently comprehensive treatments of cancer patients recognize the importance of the assessment of nutritional status and the impact it has on the prognosis quality of life and toxicity generated by cancer treatment Due to this it is imperative to offer diagnostic tools that identify patients in a timely manner and in addition to this offer therapeutic strategies for the improvement of nutritional status in an adjuvant manner to their oncological treatment
It is widely recognized that the cachexia-anorexia syndrome CACS is present in 30 to 80 of cases in cancer patients and this proportion increases as the disease progresses with weight loss being a powerful predictor of shorter survival Unfortunately current therapies available to treat anorexia and or cancer-associated cachexia offer only partial results mainly because the intervention is late and the development of an earlier and more effective intervention is still sought Mirtazapine has recently gained attention not only because of its antidepressant effect but also because of its potential benefit in patients with anorexia and weight loss recently reported in a phase II study Therefore it is important to continue its evaluation through a randomized double-blind clinical trial in which the effect of mirtazapine is compared and it is determined if it is superior compared to placebo to increase appetite in patients with NSCLC who present with anorexia
This type of strategy is a relevant therapeutic option in those patients in whom nutritional counseling by itself is not sufficient to counteract the damage caused by anorexia and to cope with or prevent the development of cachexia
Detailed Description:
Lung cancer is the leading cause of cancer death in Mexico and the world One of the comorbidities most commonly associated with this type of malignancy is malnutrition which occurs in approximately 40-50 of newly diagnosed cases In addition to its high incidence malnutrition in patients with cancer is of great relevance due to the negative effect that this entails on the quality of life and the prognosis of patients as well as the increase in toxicity associated with oncological treatment Malnutrition is a pathological state in which the deficiency in the adequate contribution of energy contributes to its development producing a systemic catabolic state Its etiology is variable however in most patients malnutrition is associated with a lack of appetite which is called anorexia
Mirtazapine is a tetracyclic antidepressant which has been widely used for the treatment of depression Several clinical studies have proven its efficacy in this indication with more than 5000 patients endorsing its clinical effect compared to placebo other tetracyclic antidepressants and trazodone In addition to its effect on mood it has been observed that mirtazapine used in standard doses induces weight gain increasing appetite and food consumption compared to patients receiving placebo
The increase in appetite with consequent weight gain and increased food intake may be due to the blocking of 5HT1b 5-HT2 5-HT3 H1 receptors involved in the regulation of appetite A pilot study of 2 doses of mirtazapine 15 or 30 mg per day in ambulatory cancer patients with pain and other discomforts suggests that it provides a significant improvement in quality of life particularly in weight and energy intake Recently another phase II study observed that 57 of oncology patients ambulatory non-depressed increased their appetite and body weight when treated with mirtazapine for 4 weeks Despite these encouraging data the study included a small sample of patients so it is not possible to generate robust conclusions from these data
The objective of this protocol is to conduct a prospective randomized double-blind clinical trial to evaluate the effect of Mirtazapine on appetite nutritional status and quality of life in patients with anorexia associated with lung cancer The sample would include 86 patients 43 patients with Mirtazapine and 43 sith placebo for 8 weeks with an inducing dose of 15 mg to a máximum of 30 mg The methodology for conducting this study consists of recruiting patients diagnosed with anorexia according to the anorexia-cachexia ACS scale which has a cut-off point specifically validated for lung cáncer Once the patient is selected they are invited to participate in the study and an informed consent is requested Subsequently a subjective global evaluation is performed a 24-hour reminder of energy consumption evaluation of anthropometric measures weight height weight loss body mass index evaluation of body composition fat fat-free mass and phase angle common gastrointestinal adverse effects of chemotherapy according to CTCAE an evaluation of anxiety and depression HADS as well as determination of quality of life through the questionnaire The European organization for research and treatment of cancer quality of life questionnaire QLQ -C30 and QLQ LC-13 validated for Mexican population
All determinations will be made at baseline at 4 and at 8 weeks All the variables are going to be evaluated inside each groups and between groups Its going to be considered significant p 005
Mirtazapine is a tetracyclic antidepressant which has been widely used for the treatment of depression Several clinical studies have proven its efficacy in this indication with more than 5000 patients endorsing its clinical effect compared to placebo other tetracyclic antidepressants and trazodone In addition to its effect on mood it has been observed that mirtazapine used in standard doses induces weight gain increasing appetite and food consumption compared to patients receiving placebo
The increase in appetite with consequent weight gain and increased food intake may be due to the blocking of 5HT1b 5-HT2 5-HT3 H1 receptors involved in the regulation of appetite A pilot study of 2 doses of mirtazapine 15 or 30 mg per day in ambulatory cancer patients with pain and other discomforts suggests that it provides a significant improvement in quality of life particularly in weight and energy intake Recently another phase II study observed that 57 of oncology patients ambulatory non-depressed increased their appetite and body weight when treated with mirtazapine for 4 weeks Despite these encouraging data the study included a small sample of patients so it is not possible to generate robust conclusions from these data
The objective of this protocol is to conduct a prospective randomized double-blind clinical trial to evaluate the effect of Mirtazapine on appetite nutritional status and quality of life in patients with anorexia associated with lung cancer The sample would include 86 patients 43 patients with Mirtazapine and 43 sith placebo for 8 weeks with an inducing dose of 15 mg to a máximum of 30 mg The methodology for conducting this study consists of recruiting patients diagnosed with anorexia according to the anorexia-cachexia ACS scale which has a cut-off point specifically validated for lung cáncer Once the patient is selected they are invited to participate in the study and an informed consent is requested Subsequently a subjective global evaluation is performed a 24-hour reminder of energy consumption evaluation of anthropometric measures weight height weight loss body mass index evaluation of body composition fat fat-free mass and phase angle common gastrointestinal adverse effects of chemotherapy according to CTCAE an evaluation of anxiety and depression HADS as well as determination of quality of life through the questionnaire The European organization for research and treatment of cancer quality of life questionnaire QLQ -C30 and QLQ LC-13 validated for Mexican population
All determinations will be made at baseline at 4 and at 8 weeks All the variables are going to be evaluated inside each groups and between groups Its going to be considered significant p 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None