The Intensive Nutritional Support in Esophageal Cancer Undergoing Neoadjuvant Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enteral Nutrition.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Intensive Nutrition Intervention in Esophagogastric Cancer Patients With Neoadjuvant Therapy: A Randomized Clinical Trial
Overview
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.
Interventions
- Dietary supplement Enteral Nutrition
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 the completion of nutritional risk screening and assessment, patients identified with nutritional risk were randomly assigned to two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the SNT group rece
Primary outcome measures
- Surgical resection rate [Time frame: Through study completion, an average of 1 year]
Secondary outcome measures (6)
- Objective response rate (ORR) [Time frame: From the start of the first neoadjuvant treatment to four weeks after the first tumor assessment.]
- The rate of pathological complete response (pCR) [Time frame: Through study completion, an average of 1 year]
- Event free survival (EFS) [Time frame: From the start of the first neoadjuvant treatment, the observation period is up to 2 years.]
- Overall survival (OS) [Time frame: From the start of the first neoadjuvant treatment, the observation period is up to 2 years.]
- Nutrition status [Time frame: Perioperative]
- Quality of life (QOL) [Time frame: Perioperative]
Eligibility criteria
Inclusion criteria
- Esophageal cancer；
- Patients were staged as cT1b-cT2N+M0 or cT3-cT4a, any N, M0. Based on the location of the tumor and clinical staging, they were defined as locally advanced resectable esophageal cancer；
- Patients planned for neoadjuvant therapy, with radical surgical resection intended after neoadjuvant treatment；
- Normal gastrointestinal function；
- PG-SGA score >3;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2分.
Exclusion criteria
- Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors;
- Have serious heart, lung and brain diseases;
- Patients with unstable vital signs and multiple organ failure;
- The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires;
- Eastern Cooperative Oncology Group score >2;
- The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable for participating in this clinical study for other reasons
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07067359 · HX2023382