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

NCT05380479 | Unknown Phase 2

• 1 other identifier: BSMMU/2022/4193
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia

Keywords

Cancer; Anorexia; Cachexia; Mirtazapine; Megestrol Acetate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Weight

  From the baseline assessment to 8 weeks]

• Body Mass Index

  From the baseline assessment to 8 weeks]

• Quality of life - physical functioning

  From the baseline assessment to 8 weeks]

• Incidence of treatment-related Adverse Events [Time Frame: 8 weeks]

  Time Frame: 8 weeks

Study Arms (2)

Mirtazapine

EXPERIMENTAL

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

Megestrol Acetate

ACTIVE COMPARATOR

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

Interventions

Mirtazapine DRUG

mirtazaine15 mg tablet daily for 8 weeks.

Mirtazapine

Megestrol Acetate DRUG

megestrol acetate 160 mg tablet daily for 8 weeks.

Megestrol Acetate

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1000, Bangladesh

RECRUITING

MeSH Terms

Conditions

Anorexia; Neoplasms; Cachexia

Interventions

Mirtazapine; Megestrol Acetate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Iftekhar Chowdhury, MD

CONTACT

+8801816197635; ichowdhury42@yahoo.com

Prof.Md.Sayedur Rahman, FCPS.M Phil

CONTACT

+8801712205305; srkhasru@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 18, 2022
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the publication of the results of study

Locations

BA (1)