Effect of Mirtazapine Versus Placebo in Patients With Non-small Cell Lung Cancer and Anorexia
NCT ID: NCT04748523
Last Updated: 2023-04-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
86 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-08-29
Study Completion Date
2022-10-29
Brief Summary
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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.
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Detailed Description
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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. It´s going to be considered significant p ≤ 0.05.
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. It´s going to be considered significant p ≤ 0.05.
Conditions
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Anorexia
Non-small Cell Lung Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Randomized, double-blind clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
The Mirtazapine and placebo containers of same appearance will be identified with a code, which will be uncovered at the end of the study. The codes assigned to Mirtazapine and placebo will be protected by the protocols coordination of the Functional Unit of Thoracic Oncology. The code will be assigned to patients in order of admission, according to a list pre-established by random numbers without knowing to which group the attending physician, the nutritionist, the psychiatrist or the patient belongs.
Study Groups
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Intervention group
arm to receive 15 to 30 mg of Mirtazapine for a period of 8 weeks.
Group Type
ACTIVE_COMPARATOR
Mirtazapine
Intervention Type
DRUG
arm to receive 15 to 30 mg of Mirtazapine for a period of 8 weeks.
Placebo group
arm to receive 15 to 30 mg of placebo for a period of 8 weeks.
Group Type
PLACEBO_COMPARATOR
Placebo Oral Tablet
Intervention Type
DRUG
arm to receive 15 to 30 mg of Placebo for a period of 8 weeks.
Interventions
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Mirtazapine
arm to receive 15 to 30 mg of Mirtazapine for a period of 8 weeks.
Intervention Type
DRUG
Placebo Oral Tablet
arm to receive 15 to 30 mg of Placebo for a period of 8 weeks.
Intervention Type
DRUG
Other Intervention Names
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Placebo
Eligibility Criteria
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Inclusion Criteria
* Outpatients over 18 years of age who are receiving care in INCan with histopathological diagnosis of advanced stage non-small cell lung cancer (IIIB or IV).
* A score ≤ 32 on the cachexia anorexia scale or ≥ 5% weight loss in the last month.
* Good performance status (ECOG 0-2)
* That they are receiving chemotherapy as standard treatment or tyrosine kinase inhibitors or immunotherapy.
* Have a life expectancy\> 8 weeks.
* Accept and sign informed consent letter.
* A score ≤ 32 on the cachexia anorexia scale or ≥ 5% weight loss in the last month.
* Good performance status (ECOG 0-2)
* That they are receiving chemotherapy as standard treatment or tyrosine kinase inhibitors or immunotherapy.
* Have a life expectancy\> 8 weeks.
* Accept and sign informed consent letter.
Exclusion Criteria
* Known allergy to mirtazapine
* Patients who are treated with antidepressants
* Patients who are under treatment with megestrol acetate
* Patients with moderate hepatic and / or renal dysfunction (bilirubin level ≥ 1.5 x above normal limits (UNL), AST and ALT ≥ 5 x UNL, or creatinine ≥5 x UNL).
* Those unable to take medication orally.
* Patients with mechanical obstruction of the gastrointestinal tract, ascites or generalized edema.
* Patients with a history of phenylketonuria (preparation contains phenylalanine).
* Patients with delirium.
* Patients who are treated with antidepressants
* Patients who are under treatment with megestrol acetate
* Patients with moderate hepatic and / or renal dysfunction (bilirubin level ≥ 1.5 x above normal limits (UNL), AST and ALT ≥ 5 x UNL, or creatinine ≥5 x UNL).
* Those unable to take medication orally.
* Patients with mechanical obstruction of the gastrointestinal tract, ascites or generalized edema.
* Patients with a history of phenylketonuria (preparation contains phenylalanine).
* Patients with delirium.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Instituto Nacional de Cancerologia de Mexico
OTHER
Sponsor Role
lead
Responsible Party
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Oscar Gerardo Arrieta Rodríguez
M.D.,M.Sc.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Oscar G Arrieta Rodriguez, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Instituto Nacional de Cancerología de México
Locations
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Instituto Nacional de Cancerologia
Mexico City, , Mexico
Site Status
Countries
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Mexico
References
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Ross PJ, Ashley S, Norton A, Priest K, Waters JS, Eisen T, Smith IE, O'Brien ME. Do patients with weight loss have a worse outcome when undergoing chemotherapy for lung cancers? Br J Cancer. 2004 May 17;90(10):1905-11. doi: 10.1038/sj.bjc.6601781.
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Langer CJ, Hoffman JP, Ottery FD. Clinical significance of weight loss in cancer patients: rationale for the use of anabolic agents in the treatment of cancer-related cachexia. Nutrition. 2001 Jan;17(1 Suppl):S1-20. doi: 10.1016/s0899-9007(01)80001-0. No abstract available.
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RESULT
Anttila SA, Leinonen EV. A review of the pharmacological and clinical profile of mirtazapine. CNS Drug Rev. 2001 Fall;7(3):249-64. doi: 10.1111/j.1527-3458.2001.tb00198.x.
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RESULT
Hilas O, Avena-Woods C. Potential role of mirtazapine in underweight older adults. Consult Pharm. 2014 Feb;29(2):124-30. doi: 10.4140/TCP.n.2014.124.
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RESULT
Kumar N, Barai S, Gambhir S, Rastogi N. Effect of Mirtazapine on Gastric Emptying in Patients with Cancer-associated Anorexia. Indian J Palliat Care. 2017 Jul-Sep;23(3):335-337. doi: 10.4103/IJPC.IJPC_17_17.
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RESULT
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RESULT
Arrieta O, Cardenas-Fernandez D, Rodriguez-Mayoral O, Gutierrez-Torres S, Castanares D, Flores-Estrada D, Reyes E, Lopez D, Barragan P, Soberanis Pina P, Cardona AF, Turcott JG. Mirtazapine as Appetite Stimulant in Patients With Non-Small Cell Lung Cancer and Anorexia: A Randomized Clinical Trial. JAMA Oncol. 2024 Mar 1;10(3):305-314. doi: 10.1001/jamaoncol.2023.5232.
Reference Type
DERIVED
Other Identifiers
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Mirtazapine
Identifier Type: -
Identifier Source: org_study_id
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