Effect of Mirtazapine Versus Placebo in Reversing Anorexia in Non-small Cell Lung cáncer Patients

• Status: Recruiting
• Trial end date: 2022-01-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cancerologia de Mexico
• Treatments: Mirtazapine

Criteria

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.

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.