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

Comparison of effectivity and safety of Olanzapine and Mirtazapine on cancer associated anorexia and cachexia in advanced oral cavity cancer patients: A prospective, comparative, interventional study - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057995

Enrollment

140

Registered

2023-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: 1. olanzapine 2. mirtazapine: To compare the effectivity and safety of Olanzapine and Mirtazapine, There will be two following groups- 1.Olanzapine group: Eligible subjects taking Olanz

Eligibility

Inclusion criteria

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) 5.Loss of appetite score 6.Patient giving written informed consent for this study 7.Who’ll give written informed consent to be included in study

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. WEIGHT 2. APPETITETimepoint: 1. change in the weight will be assessed i.e. baseline, 2nd week and 4th week 2. change in the appetite will be assessed i.e baseline, 2nd week and 4th week	—

Secondary

Measure	Time frame
1.Effect on psychological symptoms 2.Effect on sleep 3.Effect on nausea & vomiting 4.Adverse events Timepoint: 1.change in the effect on psychological symptoms will be assessed i.e. baseline, 2nd week & 4th week 2.change in the effect on sleep will be assessed i.e. baseline, 2nd week & 4th week 3.change in effect on nausea & vomiting will be assessed i.e. baseline, 2nd week & 4th week 4.Adverse events will be assessed i.e. 2nd week & 4th week after start treatment	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDR YOGENDRA SINGHAL

sawai man singh medical college and attached hospital jaipur

singhalyogi@yahoo.co.in9414850381

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026