| CTRI Number |
CTRI/2025/02/080565 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dietary Intervention] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The Role of a Prudent Diet in Enhancing Nutrition, Quality of Life, and Muscle Health After Gastric Cancer Surgery |
|
Scientific Title of Study
|
Effect of Prudent Diet on Nutritional Status, Quality of Life and Sarcopenia in Postoperative Gastric Adenocarcinoma Individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SwatiSAHS90 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahak Sharma |
| Designation |
|
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Nutrition and Dietetics, Q Block, School of Allied Health Sciences
Sector 43, Aravali Hills, Surajkund Road, Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
|
| Fax |
|
| Email |
mahak.fas@mriu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahak Sharma |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Nutrition and Dietetics, Q Block, School of Allied Health Sciences
Sector 43, Aravali Hills, Surajkund Road, Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9999560399 |
| Fax |
|
| Email |
mahak.fas@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahak Sharma |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Department of Nutrition and Dietetics, Q Block, School of Allied Health Sciences
Sector 43, Aravali Hills, Surajkund Road Faridabad, Haryana
Faridabad
HARYANA
121001
India |
| Phone |
9999560399 |
| Fax |
|
| Email |
mahak.fas@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies, Sector 43, Aravali Hills, Surajkund Road, Faridabad Haryana 121001, India |
|
|
Primary Sponsor
|
| Name |
Manav Rachna International Institute of Research and Studies |
| Address |
Sector 43 Aravali Hills, Surajkund Road, Faridabad, Haryana, 121001, India |
| Type of Sponsor |
Research institution |
|
|
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 Mohit Agarwal |
Fortis Hospital, Shalimar Bagh |
Department of Oncology, Room no.1
North
DELHI |
7042768565
swatichadha90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Committee Manav Rachna International Institute of Research and Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy Diet as per Hospital Authority |
Standard Diet Plan as per Hospital Authority will be given only once throughout the intervention phase of the study. |
| Intervention |
Name of Intervention is Prudent and Intensive Dietary Education and Comparator will be the current dietary pattern of the target group |
Personalised Prudent Diet and Nutrition Education. This will be given to the experimental group (A) for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion
Individuals affected with stage I, II and III gastric adenocarcinoma will be included in the age group of 45-60 years (Milena and Irena, 2022), ((Norman et al., 2021), (Stephan et al., 2010), (Monika et al., 2022) and (Theresa et al., 2021).
Partial gastrectomy patients will be included
Time since diagnosis is one year to one year and six months (Spinder, 2024),
Individuals should be available during the period of data collection.
Individuals can eat orally
Patients undergoing chemotherapy and radiation therapy will be included
No previous history of cancer
Low, middle, and high socioeconomic strata will be included (NRCP Stomach Cancer Report)
Individuals with pre-diabetes/ diabetes, dyslipidemia, osteoarthritis, hypo/hyperthyroidism, and hypertension will be included
|
|
| ExclusionCriteria |
| Details |
Exclusion
Critical patients/ under palliative drugs.
Individuals who are not willing to participate in the study.
Patients with hepatic cirrhosis, renal failure, stroke, chronic obstructive pulmonary disease, heart failure .
Patients with psychological disorders/mental health disorders (depression and anxiety), parkinson disease, and communication issues
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be an improvement in sarcopenia, nutritional status, and quality of life after introducing a prudent diet among postoperative gastric adenocarcinoma individuals
|
Baseline and then after 3 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dietary Diversity & Nutrition Education |
Baseline & then after 3 months of intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The growth of abnormal cells which is uncontrolled in the stomach region
is termed gastric cancer. Nine out of ten
occurrences of gastric cancer are adenocarcinomas, which are the most frequent
kind. Worldwide gastric cancer mortality is in the 3rd number due
to its aggressiveness, and spread and is under the higher incidence of sarcopenia
and malnutrition. The insufficiency of protein and calorie intake leads to poor
nutritional status and muscle loss among postoperative gastric cancer patients.
Therefore, adequate nutritional counseling and dietary support should help in
achieving appropriate nutritional goals after surgery. Owing to the anti-inflammatory and preventive
components, the prudent diet is a good dietary pattern for people with stomach
cancer. The focus includes vegetables, legumes,
fruits, whole grains, and dairy products that are low in fat, and omega-3 fats.
This study focuses on evaluating the effect of a prudent diet
on sarcopenia, nutritional status, and the quality of life amongst postoperative
individuals with gastric adenocarcinoma. An experimental study will be conducted. Single-blind
Randomized Control Trial (SBRCT) design will be used A total of 120 postoperative
gastric cancer patients (45-60 years) will be selected from the hospitals in
Delhi. The participants will be randomly allocated by an Excel random number
table into 2 experimental groups and a control group. The baseline data on
knowledge regarding nutrition in gastric cancer will be collected via a quantitative
questionnaire. The pre-intervention screening will be done on sarcopenia
(SARC-F), anthropometry, and, biomarkers of the participants will be assessed
using the CONUT Score, Hemoglobin, and Iron Profile. Imaging test reports (PET-CT)
shall be included to check for any reoccurrence during the study. Dietary
intake will be assessed through a 3-day diet recall and dietary diversity. The European
Organisation for Research and Treatment of Cancer questionnaire on gastric
cancer (STO22-QoL) will be used to collect data on the “Quality of Life” of postoperative
gastric adenocarcinoma patients. There
will be 2 experimental groups where one will be exposed to a prudent diet
(Group 1) and another will be exposed to intensive nutrition education and a prudent
diet (Group 2). The control will be exposed to basic nutrition education and a diet
plan as per hospital authority during the study. The data will be collected and analyzed using
SPSS version 29. The data will be compared with the data at baseline to check
the significant difference after imparting nutrition education and diet in the
control and experimental groups concerning knowledge, improvement in sarcopenia,
anthropometry, biomarkers, 3-day diet recall, dietary diversity, and quality of
life.
Keywords:
Partial Gastrectomy, Nutritional Counseling, Nutritional Assessment,
Nutritional Biomarkers, Dietary Intake
|