| CTRI Number |
CTRI/2024/12/078589 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Impact of Pre and Post operative Nutritional Intervention on the Nutritional Status of patients with Stomach Cancer |
|
Scientific Title of Study
|
Impact of Pre and Post operative Nutritional Intervention on the Nutritional Status of patients with Adenocarcinoma of Stomach |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kalaivani P |
| Designation |
Dietician |
| Affiliation |
sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra Institute of Higher Education and Research, Department of Clinical Nutrition,Porur, Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9677010457 |
| Fax |
|
| Email |
kalaivanip@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.A.J.Hemamalini |
| Designation |
Professor & Head |
| Affiliation |
sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra Institute of Higher Education and Research, Department of Clinical Nutrition,Porur, Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9841327708 |
| Fax |
|
| Email |
hemamalini.aj@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
kalaivani P |
| Designation |
Dietician |
| Affiliation |
sri Ramachandra institute of higher education and research |
| Address |
sri Ramachandra Institute of Higher Education and Research, Porur, Chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9677010457 |
| Fax |
|
| Email |
kalaivanip@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research, Department of Clinical Nutrition, Porur, Chennai |
|
|
Primary Sponsor
|
| Name |
kalaivani P |
| Address |
Sri Ramachandra Institute of Higher education and Research,Department of Clinical Nutrition, Porur, Chennai |
| 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 |
| kalaivani P |
Sri Ramachandra Institute of Higher Education and Research |
Department of Clinical Nutrition
Sri Ramachandra Institute of Higher Education and Research
Kancheepuram
TAMIL NADU |
9677010457
kalaivanip@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Carbo Load |
NO Carbo Load Intervention |
| Intervention |
Carbo Load |
Two sachets of carbo load will be given evening before surgery and one sachet of carbo load will be given 2 hours evening before surgery |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients newly diagnosed with adenocarcinoma of stomach stage 1,11,111 planned to undergo distal and total gastrectomy
patients with gastric cancer undergoing elective surgery following neo adjuvant chemotherapy
patients without diabetes
patients for whom at least seven days of pre and post operative nutritional intervention can be provided
patients consenting for pre operative nutrition support and carbohydrate loading |
|
| ExclusionCriteria |
| Details |
patients diagnosed with adenocarcinoma of stomach stage 4
patients in the critical care unit and critically ill gastric cancer patients and patients undergoing emergency surgery
patients diagnosed with cancer other than gastric cancer
patients with less than seven days of pre operative nutrition support will be excluded from statistical analysis
patients who is not consenting for pre operative nutrition support and carbohydrate loading
pediatric oncology
patients with diabetes |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the Phenotypic and Etiological component of nutritional status as specified by Global Leadership Initiative in Malnutrition (GLIM) criteria
To provide pre and post operative nutritional intervention to patients based on nutritional status and nutritional requirements
To evaluate the impact of nutritional intervention on the phenotypic and Etiological components of nutritional status |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay |
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included LINK).
- For how long will this data be available start date provided 20-06-2024 and end date provided 20-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patients with gastric cancer is more prone to develop severe malnutrition due to their poor oral intake. Assessment of nutritional status using adequate and appropriate measures and appropriate nutritional intervention pre and post operatively will help to enhance their muscle mass and to prevent the onset of malnutrition and its related complications. Hence this study is planned to provide pre operative nutrition support, including carbohydrate loading and implementing early post operative nutritional intervention to enhance nutritional status. |