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

NCT ID: NCT05380479

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-02-01

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.

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.

Conditions

Anorexia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mirtazapine

Intervention Type: DRUG

mirtazaine15 mg tablet daily for 8 weeks.

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.

Group Type: ACTIVE_COMPARATOR

Megestrol Acetate

Intervention Type: DRUG

megestrol acetate 160 mg tablet daily for 8 weeks.

Interventions

Mirtazapine

mirtazaine15 mg tablet daily for 8 weeks.

Intervention Type: DRUG

Megestrol Acetate

megestrol acetate 160 mg tablet daily for 8 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Dr. Iftekhar Hossain Chowdhury

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bangabandhu Sheikh Mujib Medical University

Dhaka, , Bangladesh

Site Status: RECRUITING

Countries

Bangladesh

Central Contacts

Iftekhar Chowdhury, MD

Role: CONTACT

ichowdhury42@yahoo.com

+8801816197635

Prof.Md.Sayedur Rahman, FCPS.M Phil

Role: CONTACT

srkhasru@bsmmu.edu.bd

+8801712205305

Facility Contacts

Registrar

Role: primary

registrar@bsmmu.edu.bd

+889661064

Other Identifiers

BSMMU/2022/4193

Identifier Type: -

Identifier Source: org_study_id