| CTRI Number |
CTRI/2025/07/091033 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Megesterol acetate in treating cancer related anorexia |
|
Scientific Title of Study
|
A randomised, double blind, placebo controlled trial of megestrol acetate suspension with olanzapine or olanzapine with placebo in treating symptomatic anorexia in people with advanced cancer |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOURAV KUMAR MISHRA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Associate professor
Division head Medical oncology
Department of medical oncology and hematology
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7008651823 |
| Fax |
|
| Email |
drskmishra1984@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KIRAN YGL |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Senior resident
Department of medical oncology and hematology
G-Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8123511009 |
| Fax |
|
| Email |
kiran.yglapsr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KIRAN YGL |
| Designation |
SENIOR RESIDENT |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Senior resident
Department of medical oncology and hematology
G-Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8123511009 |
| Fax |
|
| Email |
kiran.yglapsr@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All India Institute of Medical sciences,
AIIMS road, Sijua, Patrapada
Bhubaneswar, Odisha - 751019 |
| Type of Sponsor |
Government medical college |
|
|
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 Sourav Kumar Mishra |
AIIMS Bhubaneswar |
Department of Medical Oncology and Hematology
AIIMS Bhubaneswar
Sijua, Patrapada
Khordha
ORISSA |
7008651823
drskmishra1984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Megesterol acetate suspension with Olanzapine |
4 mL of Megesterol acetate suspension thrice daily for 12 weeks with Olanzapine 2.5 mg/day once daily for 12weeks |
| Comparator Agent |
Olanzapine with Placebo |
2.5mg/day Olanzapine once daily for 12 weeks with 4mL of placebo thrice daily for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Histologically or cytologically confirmed advanced cancer, treated with palliative cytotoxic chemotherapy
2) Eastern cooperative oncology group perfromance status (ECOG PS) of 0 to 3
3) Age 18years and above
4) Patient taking an oral diet
5) Normal renal and hepatic function |
|
| ExclusionCriteria |
| Details |
1)Patients diagnosed with Carcinoma Breast
2)Patients planned for or on Targeted therapy, or Immunotherapy, or Oral metronomic chemotherapy
3)Patients with concurrent radiotherapy
4)Pregnant or breastfeeding women
5)Persistent and uncontrolled nausea and/or vomiting
6)Active gastrointestinal tract obstruction
7)Patients allergic to the drugs being tested
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare gain in weight in advanced malignancies with cancer related anorexia in two arms: a.Megesterol acetate and olanzapine. b. olanzapine plus placebo
2. To compare improvement in appetite in advanced malignancies with cancer related anorexia in two arms: a.Megesterol acetate and olanzapine. b. olanzapine plus placebo
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between the 2 arms:
a. Change in quality of life (QOL)
b. Degree of nausea
c. Rate of completion of chemotherapy
d. Side effect profile of the intervention to understand the adverse events due to Megestrol acetate and olanzapine
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
01/08/2025 |
| 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="6"
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
|
Cancer-related
anorexia (CRA) affects
40%-60% of patients who have been newly diagnosed with cancer. It is associated with decreased appetite, early satiety, alterations in
taste, reduced performance status, and a lower quality of life (QOL). It leads to insufficient oral intake, compromising cancer survival. Current
guidelines for the treatment of anorexia and cachexia recommend dietary
counselling, and it will be the initial step of nutritional support that
will be offered to cancer patients who are cachectic or at-risk patients who
can eat. Common
pharmaco-therapeutic agents used for CRA are Corticosteroids, mirtazapine,
olanzapine, and megestrol acetate. Olanzapine has showed a good effect in reducing nausea and increased oral intake, it can be considered as the current standard of care for treating CRA.
Hypothesis/ Research question
We hypothesize that the addition of Megesterol acetate to olanzapine in patients with cancer related anorexia will improve appetite and will lead to gain in weight compared with olanzapine alone. |