MedTrace Logo

Effect of Mirtazapine Versus Placebo in Patients With Non-small Cell Lung Cancer and Anorexia

NCT04748523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2023-04-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Mirtazapine

arm to receive 15 to 30 mg of Mirtazapine for a period of 8 weeks.

DRUG

Placebo Oral Tablet

arm to receive 15 to 30 mg of Placebo for a period of 8 weeks.

Sponsors & Collaborators

  • Instituto Nacional de Cancerologia de Mexico

    lead OTHER

Principal Investigators

  • Oscar G Arrieta Rodriguez, M.D., M.Sc. · Instituto Nacional de Cancerología de México

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2022-07-29
Completion
2022-10-29

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04748523 on ClinicalTrials.gov