| CTRI Number |
CTRI/2025/11/097352 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Medicines, Olanzapine and Mirtazapine, for Improving Appetite and Weight in Patients with Advanced Cancer |
|
Scientific Title of Study
|
Comparison of Olanzapine and Mirtazapine on Cancer Associated Anorexia and Cachexia Syndrome in Advanced Cancer Patients: An Open Label, Prospective, Comparative, Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun Kumar Garg |
| Designation |
MD Resident |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
Department of Palliative Medicine, JLN Medical College, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
8503065598 |
| Fax |
|
| Email |
arungargmedical@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Kumar Garg |
| Designation |
Associate Professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
Department of Palliative Medicine, JLN Medical College, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9829399322 |
| Fax |
|
| Email |
drdeepakgarg04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Kumar Garg |
| Designation |
Associate Professor |
| Affiliation |
JLN Medical College, Ajmer |
| Address |
Department of Palliative Medicine, JLN Medical College, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9829399322 |
| Fax |
|
| Email |
drdeepakgarg04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Palliative Medicine, JLN Medical College, Ajmer, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Arun Kumar Garg |
| Address |
Stephen Circle, Ajmer |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arun Kumar Garg |
JLN Medical College and Hospital |
33C, Department of Palliative Medicine
Ajmer
RAJASTHAN |
8503065598
arungargmedical@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, JLN Medical College, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R634||Abnormal weight loss, (2) ICD-10 Condition: R630||Anorexia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mirtazapine |
15mg per day HS for 28 days |
| Intervention |
Olanzapine |
5mg per day HS FOR 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 years and above.
2. Registered in the palliative care centre.
3. Suffering from histologically diagnosed advanced cancer (Cancer with metastasis).
4. Patients with a weight loss of more than 5 percent of body weight over the past 6 months or loss of 2-5 percent of body weight over the past 6 months plus Body Mass Index (BMI) of less than 20.
5. Loss of appetite score (SNAQ score less than 14).
6. Patient giving written informed consent for this Study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating female.
2. Known history of hypersensitivity to study drugs.
3. Severe renal impairment (creatinine more than 2).
4. Severe liver impairment (Child Pugh score more than 10).
5. Significant disorder of bone marrow.
6. Severe cardiac impairment.
7. Patient taking antipsychotic, sedative psychotropic drug, atropine, and its substitute.
8. Non cooperative patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in body weight of the patients from baseline to the 2nd and 4th weeks after starting treatment. |
At the 2nd and 4th weeks after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in HADS (Hospital Anxiety and Depression Scale) scores |
At the 2nd and 4th weeks after starting treatment |
| Change in LSEQ (Leeds Sleep Evaluation Questionnaire) scores |
At the 2nd and 4th weeks after starting treatment |
| Change in VAS (Visual Analogue Scale) scores for nausea and vomiting |
At the 2nd and 4th weeks after starting treatment |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, open-label, comparative interventional study aims to evaluate and compare the efficacy and safety of olanzapine and mirtazapine in managing cancer-associated anorexia and cachexia syndrome (CACS) among advanced cancer patients at J.L.N. Medical College, Ajmer. A total of 140 participants will be randomly assigned equally into two groups, receiving either olanzapine 5 mg/day or mirtazapine 15 mg/day for 28 days. The primary outcome is the mean change in body weight at 2 and 4 weeks. Secondary outcomes include effects on anxiety, depression (HADS), sleep quality (LSEQ), and nausea/vomiting (VAS). Statistical significance will be assessed at p less than 0.05 to determine comparative efficacy and tolerability. |