| CTRI Number |
CTRI/2025/01/079012 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Megestrol acetate with Olanzapine on anoxia in cancer patients undergoing chemotherapy. |
|
Scientific Title of Study
|
Efficacy of olanzapine combined with megestrol acetate vs olanzapine alone when added to nutritional advice in reducing anorexia in patients undergoing chemotherapy for advanced hepato-pancreato-biliary tract, lung and genitourinary cancer - A randomized double-blind placebo controlled trial |
| 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 Anuj Gupta |
| Designation |
Associate professor |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Medical Oncology,
MPMMCC and HBCH,
Sunderpur,
Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
dr.anuj.gupta24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Kumar |
| Designation |
Senior Resident |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Medical Oncology,
MPMMCC and HBCH,
Sunderpur,
Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9874480045 |
| Fax |
|
| Email |
ravindra777ravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Kumar |
| Designation |
Senior Resident |
| Affiliation |
Mahamana Pandit Madanmohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Varanasi |
| Address |
Department of Medical Oncology,
MPMMCC and HBCH,
Sunderpur,
Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9874480045 |
| Fax |
|
| Email |
ravindra777ravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Tata Memorial Centre, Varanasi |
|
|
Primary Sponsor
|
| Name |
Dr Ravindra Kumar |
| Address |
Department of Medical Oncology,
MPMMCC and HBCH,
Sunderpur,
Varanasi- 221005 |
| 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 Ravindra Kumar |
Mahamana Pandit Madan Mohan Malviya Cancer Center |
Department of Medical Oncology, Mahamana Pandit Madan Mohan Malviya Cancer Center, Sunderpur, Sunderpur, Varanasi
Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9874480045
ravindra777ravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (3) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Olanzapine and Placebo |
Olanzapine 2.5mg OD and Placebo for 12 weeks |
| Intervention |
olanzapine combined with megestrol acetate |
olanzapine 2.5mg OD combined with megestrol acetate 160mg TDS for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Advanced hepato-pancreato-biliary tract, lung and genitourinary cancer and fit for chemotherapy.
2. Those who were willing to participate (via written consent form) in the study
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
4. Patients taking oral diet |
|
| ExclusionCriteria |
| Details |
1. Use of corticosteroids (except pre and post medication of chemotherapy)
2. Use of systemic corticosteroids (prednisolone 5mg or equivalent for more than 7 days in the previous 4 weeks)
3.Renal and/or hepatic dysfunction (Creatinine clearance ≤ 50ml/min, AST and ALT ≥ 3 times of upper limit of normal value, Total bilirubin ≥ 3mg/dl)
4. On any antipsychotic or antidepressants
5. Patients with concurrent radiotherapy
6. Mechanical obstruction of the gastrointestinal tract
7. Refractory ascites
8. Pregnancy and breast feeding
9. Diabetes mellitus (HbA1c ≥ 8%)
10. Head and neck cancer patients
11. Enrolled in another interventional trial
12. Patient require ryles tube insertion
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Weight gain |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between the 2 groups:
1. Changes in quality of Life
2. Side effect profile of the intervention (megestrol acetate and olanzapine) and to understand the adverse events
3. Stratification of anorexia in G.I. and other cancer
4. Control of symptoms of anorexia by assessing FAACT-ACS, and VAS score
5. Change in biochemical profile after intervention (albumin, lipid profile and D-dimer) |
15 months |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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)
|
31/01/2025 |
| 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="3"
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
|
When people have cancer, they often lose their appetite and lose weight. This happens because the cancer and the treatments like chemotherapy can affect the body in ways that make eating less appealing. This loss of appetite is called cancer- associated anorexia. It is a bigger problem for some types of cancer, like cancers of the stomach or lungs, where up to 80% or 60% of patients can experience this issue. Doctors have found that some medications can help with this problem. Two that are known to work are megestrol acetate and corticosteroids. However, corticosteroids can have side effects like making infections more likely, so they're not always the best choice, especially for patients undergoing chemotherapy. One interesting option being studied is olanzapine, which is a medication used for mental health conditions but also affects certain receptors in the body that can help control feelings of nausea and vomiting. This might make it useful for managing cancer-related loss of appetite and other symptoms. Studying how olanzapine works in cancers like lung, liver, gallbladder, genitourinary cancers could help doctors find better ways to help patients feel better and stay healthier during their cancer treatments. Aim of the study: To compare the efficacy of Megestrol acetate combined olanzapine vs olanzapine alone in reducing anorexia in patients undergoing chemotherapy for hepatopancreatobiliary tract, lung and genitourinary cancer. Objectives of the study: Effect of megestrol acetate combined olanzapine vs olanzapine alone on weight gain in patients undergoing chemotherapy for hepatopancreatobiliary tract, lung and genitourinary cancer. Changes in quality of Life, Side effect profile of the intervention and to understand the adverse events,Stratification anorexia in G.I. and other cancer, Control of symptoms of anorexia by assessing FAACT-ACS, and VAS score, Side effect profile of the intervention Change in biochemical profile after intervention.
Implications of The Study: Studying megestrol acetate combined with olanzapine versus olanzapine alone in cancer patients undergoing chemotherapy could offer important insights for improving treatment strategies, focusing on reducing appetite loss and enhancing overall well-being.
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