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临床试验/CTRI/2025/02/080565
CTRI/2025/02/080565招募中不适用

Effect of Prudent Diet on Nutritional Status, Quality of Life and Sarcopenia in Postoperative Gastric Adenocarcinoma Individuals

Manav Rachna International Institute of Research and Studies1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
There will be an improvement in sarcopenia, nutritional status, and quality of life after introducing a prudent diet among postoperative gastric adenocarcinoma individuals

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
45.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

There will be an improvement in sarcopenia, nutritional status, and quality of life after introducing a prudent diet among postoperative gastric adenocarcinoma individuals

时间窗: Baseline and then after 3 months of intervention

次要结局

  • Dietary Diversity & Nutrition Education(Baseline & then after 3 months of intervention)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Mahak Sharma

Manav Rachna International Institute of Research and Studies

研究点 (1)

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