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

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (Other)

Overall Status

Recruiting

CT.gov ID

NCT05380479

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia	Drug: Mirtazapine Drug: Megestrol Acetate	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Percentage of patients with Anorexia [From the baseline assessment to 8 weeks]]
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

Secondary Outcome Measures

Weight [From the baseline assessment to 8 weeks]]
Sum of all the components of the organism and represents the total body mass.
Body Mass Index [From the baseline assessment to 8 weeks]]
It is an index of the weight of a person in relation to his height BMI = Weight (Kg.) / [height (m) * height) (m)]
Quality of life - physical functioning [From the baseline assessment to 8 weeks]]
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.
Incidence of treatment-related Adverse Events [Time Frame: 8 weeks] [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.