Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05380479
Study type Interventional
Source Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Contact Iftekhar Chowdhury, MD
Phone +8801816197635
Email ichowdhury42@yahoo.com
Status Recruiting
Phase Phase 2
Start date June 1, 2022
Completion date February 1, 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT01501396 - Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite Phase 2
Withdrawn NCT02793102 - Sensory Workshops and Anorexia Nervosa N/A
Active, not recruiting NCT01206335 - Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia Phase 2
Completed NCT02524301 - Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study N/A
Active, not recruiting NCT00488072 - Effects of Mirtazapine on Appetite in Advanced Cancer Patients Phase 2
Withdrawn NCT05039385 - Exercise Program in Patients With Anorexia Nervosa (ESATRAL) N/A
Completed NCT03097874 - Adaptive Treatment for Adolescent Anorexia Nervosa N/A
Completed NCT00031785 - Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer Phase 3
Terminated NCT00535015 - Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer Phase 2
Terminated NCT00558558 - Haelan and Nutrition in Cancer Patients Phase 2
Completed NCT00040885 - Docetaxel With or Without Infliximab in Treating Weight Loss, Loss of Appetite, and Fatigue in Patients With Unresectable Non-Small Cell Lung Cancer (Infliximab Treatment Discontinued Effective 10/05/05) Phase 3
Completed NCT00006799 - Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer Phase 3
Active, not recruiting NCT03637816 - Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer Phase 2/Phase 3
Completed NCT04007900 - Positive Affect Treatment (PAT) to Target Reward Mechanisms in Anorexia Nervosa N/A
Completed NCT00735540 - Clinical Diagnosis of Teenagers Admitted to Pediatric Departments N/A
Completed NCT00046904 - Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer Phase 3
Completed NCT04803305 - Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia Phase 1
Completed NCT05708404 - Outpatient Treatment of Severe and Enduring Anorexia Nervosa
Completed NCT03283488 - Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care. Phase 2
Recruiting NCT05503147 - Sativex® and Gentamicin for Optimized Pharmagological Treatment in Older Patients (CanPan) Phase 1