| CTRI Number |
CTRI/2024/08/072844 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Olanzapine versus megestrol acetate in treating loss of appetite in patients with cancer undergoing chemotherapy |
|
Scientific Title of Study
|
olanzapine versus megastrol acetate in treating loss of appetite in patients with cancer undergoing chemotherapy |
| 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 K Pavithran |
| Designation |
Professor and HOD |
| Affiliation |
Amrita institute of medical science |
| Address |
Room No: 2
Department of medical oncology
Amrita institute of medical science
Kochi, Kerala, India
Room No: 2
Department of medical oncology
Amrita institute of medical science
Kochi, Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
9895367090 |
| Fax |
|
| Email |
pavithrank@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Murali |
| Designation |
DM RESIDENT |
| Affiliation |
Amrita institute of medical science |
| Address |
Room No: 7
Department of medical oncology
Amrita institute of medical science
Kochi, Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
8111964417 |
| Fax |
|
| Email |
anjalim@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Murali |
| Designation |
DM Resident |
| Affiliation |
Amrita institute of medical science |
| Address |
Room No: 7
Department of medical oncology
Amrita institute of medical science
Kochi, Kerala, India
Ernakulam
KERALA
682041
India |
| Phone |
8111964417 |
| Fax |
|
| Email |
anjalim@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Thesis fund from Department of medical oncology, Amrita Institute Of Medical Science |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of medical science |
| Address |
Department of medical oncology,Amrita Institute Of Medical Science, Kochi,kerala,India, Pin:682041 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 K Pavitrhran |
Amrita Institute of medical scienc |
Department of medical oncology, Amrita Institute of medical science
Ernakulam
KERALA |
9895367090
pavithrank@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECASM-AIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C788||Secondary malignant neoplasm of other and unspecified digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Megestrol 40 MG ONCE A DAY FOR 8 WEEKS |
Olanzapine is more effective and can improve appetite and promoting weight gain can help maintain or improve nutritional status and functional capacity, which are critical for supporting patient’s ability to tolerate treatment and engage in daily activities as compared to megestrol. Medications that effectively manage appetite loss may reduce the need for additional interventions, such as nutritional supplementation or hospitalizations, thereby potentially reducing healthcare costs and resource utilization. |
| Intervention |
Olanzapine 2.5 mg once a day for 8 weeks |
Olanzapine is found to more effective in improving appetite and is more cost-effective. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All stage 3 and 4 GI and lung cancer patients |
|
| ExclusionCriteria |
| Details |
Cancer patient who are on longterm steroid
pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effective agent that can prevent cachexia/anorexia associated with chemotherapy |
To find out the effective agent that can prevent cachexia/anorexia associated with chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine whether olanzapine leads to a greater proportion of patients who report a 5% or greater weight gain from baseline compared to megestrol acetate.
To compare change in cachexia/anorexia symptoms with olanzapine compared to megestrol acetate using the Functional Assessment of anorexia/cachexia treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS)instrument
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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 Yet Recruiting |
| 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
|
Olanzapine, an atypical antipsychotic, and Megestrol acetate,a synthetic progestin, exert their effects through different mechanisms, potentially offering complementary or distinct benefits in appetite stimulation. While both drugs have demonstrated efficacy in improving appetite and quality of life in cancer patients, comparative studies are sparse, making it essential to evaluate their relative effectiveness in this context. Identifying which drug offers better appetite improvement with fewer adverse effects can aid clinicians in tailoring treatment strategies to individual patient needs, ultimately optimizing symptom management and overall treatment outcomes.
PRIMARY OBJECTIVE: To determine whether olanzapine leads to greater appetite improvement from baseline in cancer patients suffering from anorexia compared to megestrol acetate using the 0-10 numerical rating scale (NRS)
SECONDARY OBJECTIVE: · To determine whether olanzapine leads to a greater proportion of patients who report a 5% or greater weight gain from baseline compared to megestrol acetate. - To compare change in cachexia/anorexia symptoms with olanzapine compared to megestrol acetate using the Functional Assessment of anorexia/cachexia treatment (FAACT)-Anorexia/Cachexia Subscale (A/CS)instrument
|