Status:
COMPLETED
Effect of Mirtazapine Versus Placebo in Patients With Non-small Cell Lung Cancer and Anorexia
Lead Sponsor:
Instituto Nacional de Cancerologia de Mexico
Conditions:
Anorexia
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2022
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04748523
Start Date
August 29 2018
End Date
October 29 2022
Last Update
April 27 2023
Active Locations (1)
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1
Instituto Nacional de Cancerologia
Mexico City, Mexico, 14080