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

NCT04748523 | Completed

• 1 other identifier: Mirtazapine
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with Anorexia

  The primary endpoint will assess the percentage of patients who continue to present anorexia after 4 and 8 weeks of treatment with placebo or mirtazapine. Anorexia will be defined as the lack of desire to eat, lack of appetite, as measured using the validated version of the Anorexia / Cachexia Scale from the Functional Assessment of Anorexia Cachexia Therapy (FAACT). A score of less than or equal to 24 will be considered diagnostic for anorexia.

  From the baseline assessment to 4 and 8 weeks

• Energy Consumption

  Total kilocalories consumed on average per day by a subject

  From the baseline assessment to 4 and 8 weeks

Secondary Outcomes (20)

• Weight

  From the baseline assessment to 8 weeks

• Body Mass Index

  From the baseline assessment to 8 weeks

• Subjetive Global Assessment

  From the baseline assessment to 8 weeks

• Protein consumption

  From the baseline assessment to 8 weeks

• Lipids consumption

  From the baseline assessment to 8 weeks

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Drug: Mirtazapine

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Mirtazapine DRUG

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

Intervention group

Placebo Oral Tablet DRUG

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

Also known as: Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: adults
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia de Mexico: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, 14080, Mexico

Location

Related Publications (25)

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MeSH Terms

Conditions

Anorexia; Carcinoma, Non-Small-Cell Lung

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Oscar G Arrieta Rodriguez, M.D., M.Sc.

  Instituto Nacional de Cancerología de México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,M.Sc.

Model Details: Randomized, double-blind clinical trial

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: February 10, 2021
• Study Start: August 29, 2018
• Primary Completion: July 29, 2022
• Study Completion: October 29, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)