## Protocol Section
### Identification Module
**NCT ID:** NCT05380479

**Brief Title:** Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients.

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

#### Organization Study ID Info
**ID:** BSMMU/2022/4193
#### Organization
**Class:** OTHER
**Full Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
### Status Module
#### Completion Date
**Date:** 2023-02-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-05-18

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-17

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2022-05-18
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-10
**Study First Submit QC Date:** 2022-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

#### Responsible Party

**Investigator Affiliation:** Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

**Investigator Full Name:** Dr. Iftekhar Hossain Chowdhury

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Anorexia

**Keywords:**

- Cancer

- Anorexia

- Cachexia

- Mirtazapine

- Megestrol Acetate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Drug: Mirtazapine

**Label:** Mirtazapine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Megestrol Acetate

**Label:** Megestrol Acetate

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mirtazapine

**Description:** mirtazaine15 mg tablet daily for 8 weeks.

**Name:** Mirtazapine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Megestrol Acetate

**Description:** megestrol acetate 160 mg tablet daily for 8 weeks.

**Name:** Megestrol Acetate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Percentage of patients with Anorexia

**Time Frame:** From the baseline assessment to 8 weeks]

#### Secondary Outcomes

**Description:** Sum of all the components of the organism and represents the total body mass.

**Measure:** Weight

**Time Frame:** From the baseline assessment to 8 weeks]

**Description:** It is an index of the weight of a person in relation to his height BMI = Weight (Kg.) / \[height (m) \* height) (m)\]

**Measure:** Body Mass Index

**Time Frame:** From the baseline assessment to 8 weeks]

**Description:** 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.

**Measure:** Quality of life - physical functioning

**Time Frame:** From the baseline assessment to 8 weeks]

**Description:** 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.

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

**Time Frame:** Time Frame: 8 weeks

### Eligibility Module

**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.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ichowdhury42@yahoo.com

**Name:** Iftekhar Chowdhury, MD

**Phone:** +8801816197635

**Role:** CONTACT

**Contact 2:**

**Email:** srkhasru@bsmmu.edu.bd

**Name:** Prof.Md.Sayedur Rahman, FCPS.M Phil

**Phone:** +8801712205305

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Dhaka

**Contacts:**

***Contact 1:***

- **Email:** registrar@bsmmu.edu.bd

- **Name:** Registrar

- **Phone:** +889661064

- **Role:** CONTACT

**Country:** Bangladesh

**Facility:** Bangabandhu Sheikh Mujib Medical University

**Status:** RECRUITING

**Zip:** 1000

### IPD Sharing Statement Module

**Description:** The result of this research will be published as an article in a journal

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

**IPD Sharing:** YES

**Time Frame:** After the publication of the results of study

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000015431

- Term: Weight Loss

- ID: D000001836

- Term: Body Weight Changes

- ID: D000001835

- Term: Body Weight

- ID: D000013851

- Term: Thinness

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000009748

- Term: Nutrition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M4181

- Name: Anorexia

- Relevance: HIGH

- As Found: Anorexia

- ID: M21265

- Name: Wasting Syndrome

- Relevance: HIGH

- As Found: Cachexia

- ID: M5363

- Name: Cachexia

- Relevance: HIGH

- As Found: Cachexia

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M18102

- Name: Weight Loss

- Relevance: LOW

- As Found: Unknown

- ID: M5115

- Name: Body Weight Changes

- Relevance: LOW

- As Found: Unknown

- ID: M16614

- Name: Thinness

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000019282

- Term: Wasting Syndrome

- ID: D000000855

- Term: Anorexia

- ID: D000002100

- Term: Cachexia

### Intervention Browse Module - Ancestors

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000006634

- Term: Histamine H1 Antagonists

- ID: D000006633

- Term: Histamine Antagonists

- ID: D000018494

- Term: Histamine Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000058669

- Term: Adrenergic alpha-2 Receptor Antagonists

- ID: D000000317

- Term: Adrenergic alpha-Antagonists

- ID: D000018674

- Term: Adrenergic Antagonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000058830

- Term: Serotonin 5-HT2 Receptor Antagonists

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000058831

- Term: Serotonin 5-HT3 Receptor Antagonists

- ID: D000003278

- Term: Contraceptives, Oral, Hormonal

- ID: D000003276

- Term: Contraceptives, Oral

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000019167

- Term: Appetite Stimulants

- ID: D000000697

- Term: Central Nervous System Stimulants

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

### Intervention Browse Module - Browse Leaves

- ID: M11518

- Name: Megestrol

- Relevance: HIGH

- As Found: January

- ID: M21272

- Name: Megestrol Acetate

- Relevance: HIGH

- As Found: Caucasian

- ID: M2007

- Name: Mirtazapine

- Relevance: HIGH

- As Found: Inadequate

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M9710

- Name: Histamine H1 Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9708

- Name: Histamine

- Relevance: LOW

- As Found: Unknown

- ID: M212144

- Name: Histamine phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M9709

- Name: Histamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29195

- Name: Adrenergic alpha-2 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M3669

- Name: Adrenergic alpha-Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20755

- Name: Adrenergic Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M29246

- Name: Serotonin 5-HT3 Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: M6502

- Name: Contraceptives, Oral, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008535

- Term: Megestrol

- ID: D000019290

- Term: Megestrol Acetate

- ID: D000078785

- Term: Mirtazapine

### Misc Info Module

- Version Holder: 2024-05-24
