| CTRI Number |
CTRI/2025/04/084037 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
An open-label, randomized control trial to Determine the optimal dose of megestrol acetate in advance stage cancer patients having anorexia cachexia syndrome. |
|
Scientific Title of Study
|
An open-label,phase III randomized control trial to observe the weight gain and appetite improvement with use of Megestrol in advanced stage cancer patients having anorexia and cachexia syndrome |
| 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 Kunal Ranjan Vinayak |
| Designation |
Assistant Professor |
| Affiliation |
HBCH AND MPMMCC Varanasi |
| Address |
BHU Campus Sundarbagiya Sunderpur Varanasi 221005
BHU Campus Sundarbagiya Sunderpur Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8828362082 |
| Fax |
|
| Email |
kunal@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kunal Ranjan Vinayak |
| Designation |
Assistant Professor |
| Affiliation |
HBCH AND MPMMCC Varanasi |
| Address |
BHU Campus Sundarbagiya Sunderpur Varanasi 221005
BHU Campus Sundarbagiya Sunderpur Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8828362082 |
| Fax |
|
| Email |
kunal@mpmmcc.tmc.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kunal Ranjan Vinayak |
| Designation |
Assistant Professor |
| Affiliation |
HBCH AND MPMMCC Varanasi |
| Address |
BHU Campus Sundarbagiya Sunderpur Varanasi 221005
BHU Campus Sundarbagiya Sunderpur Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8828362082 |
| Fax |
|
| Email |
kunal@mpmmcc.tmc.gov.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial centre Administrative Research Council |
| Address |
Dr Ernest Borges Marg Parel Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kunal Ranjan Vinayak |
OPD 18 & OPD 41 Department of Palliative Medicine MPMMCC VARANASI |
Sunderbagiya BHU CAMPUS
Varanasi
UTTAR PRADESH |
8828362082
kunal@mpmmcc.tmc.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 |
| Comparator Agent |
MEGESTROL |
To compare the safety and efficacy weight gain and appetite improvement of megestrol when given in two doses 480 mg per day |
| Intervention |
MEGESTROL |
To compare the safety and efficacy weight gain and appetite improvement of megestrol when given in two doses160mg per day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with 18 years and above
2 Advance Stage Patients with confirmed diagnosis of ACS
3 Loss of Greater than 5 Percent pre illness of body weight in the previous 3 months
4 Life expectancy of Greater or Equal to 4 months
5 Patients receiving palliative treatment or supportive care |
|
| ExclusionCriteria |
| Details |
1 Patient with history of hypertension and diabetes mellitus
2 Mechanical obstruction to feeding
3 Pregnant women or breast-feeding women
4 History of thromboembolism and edema
5 Patients already on alternative medications that may significantly show improvement in weight gain
6 Patients refuse to consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome
1. To compare weight and appetite improvement in participants in both arms.
Secondary Outcome –
1. To compare quality of life at baseline and 4 weekly till the primary endpoint.
2. To compare adverse events in both arms. |
12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome –
1. To compare quality of life at baseline and 4 weekly till the primary endpoint.
2. To compare adverse events in both arms. |
12weeks |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="252"
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)
|
26/05/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
An open label, randomized control trial to observe the weight gain and appetite improvement with use of megestrol in advanced stage cancer patients having anorexia cachexia syndrome. ACS is a combination of anorexia (loss of appetite) and atrophy (decrease in size and wasting of body part) of adipose and skeletal muscle, which affects nearly 35-40% of patients with advanced-stage cancer. Megestrol Acetate (MA) is commonly used to treat ACS, and its effectiveness has been proven in several studies. However, there is no consensus on the optimal dosage of MA, which could cause toxicity in patients, resulting in additional problems like skeletal muscle loss, sarcopenia, and physical frailty. This study aims to determine the optimal dose of MA to treat ACS with the least toxicity possible. The study will help understand the appropriate dosage of MA that can show effects without causing harmful side effects or increasing the economic burden to the patient. Objectives: Primary Objective – 1. To compare the safety and efficacy (weight gain and appetite improvement) of megestrol when given in two doses,160mg/day or 480mg/day to advance stage cancer patients with anorexia-cachexia syndrome. Secondary Objectives – 1. To observe the adverse drug reaction in both arms. 2. To compare quality of life in both arms. Methodology: The study will be conduct for the period of 2 year and the participants in the study will be randomize into two arms – 1. 1. Arm A – In Arm A, participants will receive oral megestrol of total dose of 480mg/day for 12 weeks. 2. Arm B – In Arm B, participants will receive oral megestrol of total dose 160mg/day for 12 weeks. In both arms, patients will receive treatment for 12 weeks and will be followed-up for 4 weeks to assess the efficacy and toxicities of treatment. Outcome Measure: Primary outcome – 1. To compare weight and appetite improvement in participants in both arms. Secondary Outcome – 1. To compare quality of life at baseline and 4 weekly till the primary endpoint. 2. To compare adverse events in both arms. In both arms, patients will be given treatment and accessed for efficacy, quality of life and toxicities up to 12 weeks to capture weight and appetite gain and toxicities (if any) from megestrol.
|