Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients.

Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients: A Randomized, Double-Blind Trail.

This study was 8 weeks randomized, double-blind trail to assess the effect of mirtazapine versus megestrol acetate in treatment of anorexia-cachexia in advanced cancer patients in 80 patients. Participants were assessed at baseline, 4 weeks and 8 weeks. Subject were randomized to receive either mirtazapine 15 mg tablet daily or megestrol acetate 160 mg tablet daily for 8 weeks. The primary outcome was the measure of FAACT(A/C) score and the secondary measure includes weight, BMI, quality of life and evaluate adverse effects.

Study Overview

• Status: Recruiting
• Conditions: Anorexia
• Intervention / Treatment: Drug: Mirtazapine; Drug: Megestrol Acetate

Detailed Description

Cancer-related cachexia and anorexia (CRCA) comprises one of the most common syndrome of advanced cancers characterize by anorexia, tissue wasting and loss of body weight accompanied by a decrease in muscle mass and adipose tissue and by poor performance status that often precedes death . Death usually occurs when there is a 30% weight loss. The prevalence of CRCA increases from 50 to 80% before death, and in more than 20% of cancer patients, it is the cause of death. Cancer-related cachexia and anorexia (CRCA) is associated not only with impaired quality of life in patients and family members but also with shorter survival. The management of cancer-related cachexia and anorexia (CRCA) is a great challenge in clinical practice. To date, practice guidelines for the prevention and treatment of CRCA are lacking. Although megestrol acetate and dexamethasone have shown benefits for CRCA in terms of weight gain. There is no definitive evidence that these agents improve patient quality of life. This proposed study is therefore an effort whether there is any role of mirtazapine to improvement of anorexia in cancer patients. This study will be a randomized, double-blind, clinical trial. It will be conducted in the department of pharmacology, BSMMU in collaboration with the department of clinical oncology, BSMMU, NIRCH & Delta Hospital from the day of approval by the IRB to June, 2022. A total of eighty (80) patients attend in the outpatient department of clinical oncology, BSMMU, NIRCH & Delta Hospital diagnosed as cancer anorexia will be selected for the study according to inclusion and exclusion criteria. Then participants will randomly be assigned into two intervention groups. The cancer anorexia of each participant will be assessed by Functional Assessment of Anorexia/Cachexia Therapy at baseline. The group A (40) will receive mirtazapine15mg tablet and other group B (40) will receive megestrol acetate160mg tablet orally once a day for 8 weeks. After 4 and 8 weeks each participant will be assessed once again by Functional Assessment of Anorexia/Cachexia Therapy. The quality of life of CRAC each participant will be assessed by EORTC QLQ-C30.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Iftekhar Chowdhury, MD; Phone Number: +8801816197635; Email: ichowdhury42@yahoo.com
• Study Contact Backup: Name: Prof.Md.Sayedur Rahman, FCPS.M Phil; Phone Number: +8801712205305; Email: srkhasru@bsmmu.edu.bd

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 1000
    • Recruiting
    • Bangabandhu Sheikh Mujib Medical University
    • Contact: Registrar; Phone Number: +889661064; Email: registrar@bsmmu.edu.bd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged ≥ 18 years, with a histologically diagnosed advanced-stage tumor at any site.
• Assumptive or documented loss of >5% of pre-illness or ideal body weight (body mass index) in the previous 3 months.
• Patients could be receiving concomitant chemotherapy, radiotherapy and/or palliative supportive care.
• Patients ECOG Performance Status 0-3.

Exclusion Criteria:

• Patients with a mechanical obstruction to feeding.
• Patients with high doses of corticosteroids.
• Patients with clinically bulky ascites and generalized edema.
• Patients with inability to take oral medications.
• History of uncontrolled diabetes mellitus and hypertension.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirtazapine; Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night. This group will consist of 40 patients with anorexia in advanced cancer patients.	Drug: Mirtazapine; mirtazaine15 mg tablet daily for 8 weeks.
Active Comparator: Megestrol Acetate; Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night This group will consist of 40 patients with anorexia in advanced cancer patients.	Drug: Megestrol Acetate; megestrol acetate 160 mg tablet daily for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with Anorexia	The primary endpoint will assess the percentage of patients who continue to present anorexia after 8 weeks of treatment. 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 8 weeks]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Sum of all the components of the organism and represents the total body mass.	From the baseline assessment to 8 weeks]
Body Mass Index	It is an index of the weight of a person in relation to his height BMI = Weight (Kg.) / [height (m) * height) (m)]	From the baseline assessment to 8 weeks]
Quality of life - physical functioning	The physical functioning will be evaluated using the validated Bangla version of the European Organization for the Research and Treatment of Cancer (EORTC) Quality of life questionnaires specific for cancer using the physical functioning scale (from QLQ-C30 version 3.0).The Change over time as well as the difference between groups will be analyzed.	From the baseline assessment to 8 weeks]
Incidence of treatment-related Adverse Events [Time Frame: 8 weeks]	The questioning about the occurrence of treatment-related adverse events will also be performed at the outpatient clinic at baseline and weeks 4 and 8 during the follow-up.	Time Frame: 8 weeks

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Cancer; Cachexia; Anorexia; Mirtazapine; Megestrol Acetate
• Additional Relevant MeSH Terms: Metabolic Diseases; Signs and Symptoms, Digestive; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Anorexia; Wasting Syndrome; Cachexia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Contraceptives, Oral, Hormonal; Central Nervous System Stimulants; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Appetite Stimulants; Mirtazapine; Megestrol; Megestrol Acetate
• Other Study ID Numbers: BSMMU/2022/4193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The result of this research will be published as an article in a journal
• IPD Sharing Time Frame: After the publication of the results of study
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No