To compare the effectivity and safety of Olanzapine and Mirtazapine on cancer associated anorexia and cachexia in advanced oral cavity cancer patients

Phase 4

• Conditions: Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

• Registration Number: CTRI/2023/09/057995
• Lead Sponsor: nil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age 18 years and above

2.Registered in palliative care centre

3.Suffering from an histologically diagnosed advanced oral cavity cancer (Cancer with Mets)

4.Patients with a weight loss >5% of body weight over past 6 month OR loss of 2-5% of body weight over past 6 month plus body mass index (BMI) <20

5.Loss of appetite score <14

6.Patient giving written informed consent for this study

7.Who’ll give written informed consent to be included in study

Exclusion Criteria

1.Pregnant and lactating female

2.Known history of hypersensitive to study drugs

3.Severe renal impairment,

4.Severe liver impairment,

5.Significant disorder of bone marrow

6.Cardiac conduction defect.

7.Patient taking Antipsychotic, sedative- psychotropic drug, Atropine and its substitute.

8.Non co-operative patient

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. WEIGHT <br/ ><br>2. APPETITETimepoint: 1. change in the weight will be assessed i.e. baseline, 2nd week and 4th week <br/ ><br>2. change in the appetite will be assessed i.e baseline, 2nd week and 4th week

Secondary Outcome Measures

Name	Time	Method
1.Effect on psychological symptoms <br/ ><br>2.Effect on sleep <br/ ><br>3.Effect on nausea & vomiting <br/ ><br>4.Adverse events <br/ ><br>Timepoint: 1.change in the effect on psychological symptoms will be assessed i.e. baseline, 2nd week & 4th week <br/ ><br>2.change in the effect on sleep will be assessed i.e. baseline, 2nd week & 4th week <br/ ><br>3.change in effect on nausea & vomiting will be assessed i.e. baseline, 2nd week & 4th week <br/ ><br>4.Adverse events will be assessed i.e. 2nd week & 4th week after start treatment <br/ ><br>