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CTRI Number  CTRI/2024/04/065062 [Registered on: 02/04/2024] Trial Registered Prospectively
Last Modified On: 02/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Survey]  
Study Design  Other 
Public Title of Study   Can We Help Stomach Cancer Survivors Feel Better After Surgery in India 
Scientific Title of Study   The feasibility and acceptability of conducting a randomised controlled trial to improve Body Composition and Quality of Life of stomach cancer patients after Total gastrectomy in India (EASE IN) 
Trial Acronym  EASE IN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manish Bhandare 
Designation  Professor and Surgeon 
Affiliation  Tata Memorial Hospital 
Address  GI OPD HBB 3rd floor tata memorial centre Parel Mumbai
GI OPD HBB 3rd floor tata memorial centre Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  7738389116  
Fax    
Email  manishbhandare@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Bhandare 
Designation  Professor and Surgeon 
Affiliation  Tata Memorial Hospital 
Address  GI OPD HBB 3rd floor tata memorial centre Parel Mumbai
GI OPD HBB 3rd floor tata memorial centre Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  7738389116  
Fax    
Email  manishbhandare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manish Bhandare 
Designation  Professor and Surgeon 
Affiliation  Tata Memorial Hospital 
Address  GI OPD HBB 3rd floor tata memorial centre Parel Mumbai
GI OPD HBB 3rd floor tata memorial centre Parel
Mumbai
MAHARASHTRA
400012
India 
Phone  7738389116  
Fax    
Email  manishbhandare@gmail.com  
 
Source of Monetary or Material Support  
Homi bhabha block 3rd floor GI OPD Tata Memorial Hospital Parel mumbai 400012 india 
 
Primary Sponsor  
Name  University of Aberdeen 
Address  Health Sciences Building Forresterhill Aberdeen Ab25 2ZD United Kingdom 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manish Bhandare  Tata memorial hospital  GI OPD Homi bhabha building 3rd floor Tata Memorial Hospital Parel
Mumbai
MAHARASHTRA 		 7738389116

manishbhandare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata memorial centre institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control  The control group will receive routine care provided by the hospital. Body composition, and Quality of Life measures will be collected at the time of discharge and collected every four months during follow-up visits. Diet and physical activity measures will be collected at the start and end of the study. 
Intervention  Intervention  The intervention group will receive the tailored diet and physical activity lifestyle intervention delivered by telephone fortnightly. The level of intervention received will be based on body composition, diet and physical activity measures collected at the time of discharge. These measures, along with the quality of life, will be collected every four months during follow-up visits. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with stomach cancer who had a total gastrectomy and chemotherapy
Only patients from Greater Mumbai region 
 
ExclusionCriteria 
Details  Patients who had other cancers in the past two years
Patients who underwent or will undergo radiotherapy (approximately 2% of the patients)
Patients who had an extensive resection due to cancer spreading to other parts of the body (resection extended to spleen or oesophagus) that could result in increased post-operative complications
Patients with severe frailty or dementia (based on self-reporting or medical records)
Patients who might need tubal feeding following their gastrectomy
Patients who have physical or mental health conditions that could limit consenting to the study or complying with the diet and physical activity recommendations 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome: Body composition will be measured using various indicators, including body mass index, adiposity measured using waist circumference and lean and fat mass measured using bioelectrical impedance analysis (Quantitative data).  24 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome: Quality of Life will be measured using the QLQ-C305 (Quantitative data).
ï‚· The feasibility outcomes will assess eligibility, acceptability, recruitment, and retention rates. (Quantitative data and Qualitative Data). 		 24 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2 
Date of First Enrollment (India)   11/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/04/2024 
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)   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  

Previous research suggests that Indian cancer survivors experience poor health and wellbeing. Little is known about stomach cancer survivors’ body composition (BC) post total gastrectomy in India despite evidence suggesting that BC could affect survival, and quality of life (QoL). The first 6-12 months post-gastrectomy are important to establish a ‘new normal for eating’ that is informed by understanding of dietary changes and eating behaviour.

The project aims to determine whether using information about body composition can help tailor a diet and physical activity lifestyle intervention (IBC) and is feasible and acceptable to stomach cancer survivors who recently completed treatment. We will also assess whether using this information can improve cancer survivors’ body composition and quality of life.

All the patients will be followed up till 8 months post primary surgeryand the intervention group will receive the tailored diet and physical activity lifestyle intervention delivered by telephone fortnightly. The level of intervention received will be based on body composition, diet and physical activity measures collected at the time of discharge. These measures, along with the quality of life, will be collected every four months during follow-up visits.

We expect to strengthen understanding of the impact of integrating body composition measures into diet and physical activity lifestyle intervention (IBC) to improve QoL.

 
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