| CTRI Number |
CTRI/2024/09/073624 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prehabilitation include Exercises, Nutrition, Psychological counselling] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prehabilitation programme for upper Gastrointestinal tract cancer patients |
|
Scientific Title of Study
|
Effect of multimodal home based prehabilitation programme on overall complications in patient undergoes surgery for esophagogastric 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 |
Dr Sachin Jivani |
| Designation |
First year DrNB trainee |
| Affiliation |
Medanta- The Medicity |
| Address |
Division of Surgical Gastroenterology, Medanta- The Medicity, Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9714106191 |
| Fax |
|
| Email |
sachinjivani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archit Gupta |
| Designation |
Consultant |
| Affiliation |
Medanta- The Medicity |
| Address |
Division of Surgical Gastroenterology, Medanta- The Medicity, Gurgaon, Haryana, India, PIN Code-122001
Gurgaon
HARYANA
122001
India |
| Phone |
7018071288 |
| Fax |
|
| Email |
archit9th@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Jivani |
| Designation |
First year DrNB trainee |
| Affiliation |
Medanta- The Medicity |
| Address |
Division of Surgical Gastroenterology, Medanta- The Medicity, Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
9714106191 |
| Fax |
|
| Email |
sachinjivani@gmail.com |
|
|
Source of Monetary or Material Support
|
| 11th floor OPD, Division of Surgical Gastroenterology, Medanta- The Medicity, Gurgaon, Haryana, India, PIN Code-122001 |
|
|
Primary Sponsor
|
| Name |
Division of Surgical Gastroenterology |
| Address |
11th floor OPD building, Division of Surgical Gastroenterology, Medanta- The Medicity, Gurgaon, Haryana, India, PIN Code-122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sachin Jivani |
Medanta- The Medicity |
11th floor OPD building, Division of Surgical Gastroenterology, Medanta- The Medicity, Gurgaon, Haryana, India, PIN Code-122001
Gurgaon
HARYANA |
9714106191
sachinjivani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (2) ICD-10 Condition: C16||Malignant neoplasm of stomach, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Given standard care. Not be provided with any specific recommendations for prehabilitation before surgery. |
| Intervention |
Prehabilitation |
Components including structured physical exercise, nutritional support, psychological counselling, and cessation of smoking and alcohol intake.
1.) A personalized, home-based exercise regimen will be prescribed by a physiotherapist. This regimen will entail sessions of incentive spirometry (3 sessions, each consisting of 3 sets of 10 inspiratory efforts with 5 minutes gap), Deep inspiration training and diaphragmatic breathing (The patient will lie on a flat surface and place one hand on the upper chest and the other below the rib cage to feel the movement of the diaphragm while breathing. Inhalation will be done slowly through the nose, causing the stomach to rise against the hand. Exhalation will involve tightening the stomach muscles and letting them fall inward while exhaling through pursed lips.), sit to stand (3 sets, 30 seconds each set) and climbing stairs/bicycling (2 sessions, 15 minutes per session).
2.) Nutritional support will involve protein supplementation with protein powder to fulfil daily protein requirements (1.5 g/kg of body weight) and calorie intake (35 kcal/kg of body weight), along with iron and multivitamin supplements. Patients will be instructed to ingest the protein supplement within one hour after their exercise routine to optimize muscle protein synthesis following exercise.
3.) During the initial visit, counseling and encouragement for quitting smoking and alcohol consumption will be provided. If necessary, psychological counseling will also be offered to enhance engagement and improve program effectiveness during the first visit.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All esophago-gastric cancer patient undergoing curative surgical resection –esophageal carcinoma, gastroesophageal junction carcinoma, and gastric carcinoma
2. Age ≥18 year
3. Willing to participate in the study
4. American Society of Anaesthesiologists physical status classes (ASA) score of ≤ 3
|
|
| ExclusionCriteria |
| Details |
1. Patients not giving informed consent
2. Patients found to have unresectable disease (locally advanced/ metastatic)
3. Inability to perform prescribed exercises
4. American Society of Anaesthesiologists physical status classes 4 and 5,
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall complications as per Clavien Dindo classification |
30 days after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative pneumonia |
30 days |
| Hours of postoperative mechanical ventilation |
30 days |
| Postoperative hours of ICU stay |
30 days |
| Postoperative days of hospital stay |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/09/2024 |
| 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="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
|
Patients scheduled for esophago-gastric cancer surgery at Medanta Hospital will be enrolled in a multimodal prehabilitation program after randomization. This program will commence at least 2 weeks prior to the surgery and will encompass various components including structured physical exercise, nutritional support, psychological counselling, and cessation of smoking and alcohol intake. Patients will be provided with booklets to record daily self-assessments, and weekly assessments will be conducted by medical professionals. Adherence to the prehabilitation protocol for a minimum of two weeks will be mandatory. The leaflets will be collected from patients upon admission before surgery. The analysis will include profiling of patients on different demographic, clinical and laboratory parameters. Descriptive analysis of quantitative parameters will be expressed as means and standard deviation. Categorical data will be expressed as absolute number and percentage. Independent Student t – test will be used for testing of mean between independent groups. Cross tables will be generated and Chi square test will be used for testing of associations. P-value < 0.05 will be considered statistically significant. Patients will be followed up until discharge and up to 30 days following surgery. In case of readmission for the surgical complications within 30 days and surgical complications related mortality, the necessary data will be collected. Clearer evidence that will most likely emerge from the analysis of the data will serve as useful reference for upper GI surgeons in India and around the world about effect of prehabilitation on postoperative complication in patients undergoing surgery for esophagogastric cancer.
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