Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT07067359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Intensive Nutritional Support in Esophageal Cancer Undergoing Neoadjuvant Therapy
Sponsor:
Sichuan University
Organization:
Study Overview
Official Title:
Effect of Intensive Nutrition Intervention in Esophagogastric Cancer Patients With Neoadjuvant Therapy: A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSECNT
Brief Summary:
Patients with esophageal cancer undergoing neoadjuvant therapy were selected as research subjects for nutritional risk screening and malnutrition assessment. Patients identified with nutritional risk were randomized into the standard nutrition therapy group (SNT) and the intensive nutrition therapy group (INT). The surgical rate was evaluated in both groups of patients, and the effects of nutritional support therapy on nutritional status and quality of life were investigated.
Detailed Description:
Esophageal cancer is one of the most common malignant tumors in China, with high incidence and mortality rates. Due to its anatomical location and pathological characteristics, patients with esophageal cancer often experience symptoms such as dysphagia and reduced appetite at an early stage of the disease, leading to inadequate nutritional intake and subsequent malnutrition. Malnutrition not only weakens the immune function of patients but also reduces their tolerance to surgery, radiotherapy, and chemotherapy. It may also prolong hospital stays, increase the incidence of complications, and ultimately affect patient prognosis and quality of life. Therefore, conducting nutritional risk screening and malnutrition assessment for patients with esophageal cancer, and providing targeted nutritional support therapy based on these assessments, is of significant importance for improving clinical outcomes.
This study selected patients with esophageal cancer undergoing neoadjuvant therapy as the research subjects. All enrolled patients underwent comprehensive nutritional risk screening and malnutrition assessment prior to enrollment. After completing the nutritional risk screening and assessment, patients identified with nutritional risk were randomly divided into two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the Standard Nutrition Therapy group (SNT) received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In contrast, patients in the Intensive Nutrition Therapy group (INT) not only received the standard regimen but also continued to receive ongoing nutritional counseling and monitoring after discharge, ensuring sustained nutritional support for the patients.
The primary research content of this study includes the surgical resection rate. By comparing the surgical rates between the two groups of patients, the impact of different nutritional support regimens on patients' surgical opportunities was assessed. Additionally, the effectiveness of nutritional support therapy in improving patients' nutritional status was evaluated by regularly monitoring changes in nutritional indicators such as body weight, body mass index (BMI), and serum albumin levels.
This study aims to provide high-quality clinical evidence for the nutritional support treatment of patients with esophageal cancer through a randomized controlled trial. We anticipate that patients in the intensive nutrition therapy group will outperform those in the standard nutrition therapy group in terms of surgical rates and improvement in nutritional status. Through this study, we hope to further optimize the nutritional management strategies for patients with esophageal cancer, provide more targeted nutritional support regimens for clinicians, and thereby improve patient prognosis.
This study selected patients with esophageal cancer undergoing neoadjuvant therapy as the research subjects. All enrolled patients underwent comprehensive nutritional risk screening and malnutrition assessment prior to enrollment. After completing the nutritional risk screening and assessment, patients identified with nutritional risk were randomly divided into two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the Standard Nutrition Therapy group (SNT) received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In contrast, patients in the Intensive Nutrition Therapy group (INT) not only received the standard regimen but also continued to receive ongoing nutritional counseling and monitoring after discharge, ensuring sustained nutritional support for the patients.
The primary research content of this study includes the surgical resection rate. By comparing the surgical rates between the two groups of patients, the impact of different nutritional support regimens on patients' surgical opportunities was assessed. Additionally, the effectiveness of nutritional support therapy in improving patients' nutritional status was evaluated by regularly monitoring changes in nutritional indicators such as body weight, body mass index (BMI), and serum albumin levels.
This study aims to provide high-quality clinical evidence for the nutritional support treatment of patients with esophageal cancer through a randomized controlled trial. We anticipate that patients in the intensive nutrition therapy group will outperform those in the standard nutrition therapy group in terms of surgical rates and improvement in nutritional status. Through this study, we hope to further optimize the nutritional management strategies for patients with esophageal cancer, provide more targeted nutritional support regimens for clinicians, and thereby improve patient prognosis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: