The Intensive Nutritional Support in Esophageal Cancer Undergoing Neoadjuvant Therapy
ConditionEsophageal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSichuan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Enteral Nutrition
Dietary supplementThis 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 received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In addition to the standard regimen, patients in the INT group continued to receive ongoing nutritional counseling and nutritional supplement support after discharge to ensure sustained nutritional support.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Intensive Nutrition therapy (INT)Experimental treatment 1 intervention
Group B: Standard Nutrition Therapy (SNT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Surgical resection rate
The proportion of esophageal cancer patients who undergo radical surgical resection after neoadjuvant therapy.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Objective response rate (ORR)
The Objective Response Rate (ORR) refers to the proportion of patients whose tumor lesions completely disappear (Complete Response, CR) or partially shrink (Partial Response, PR) during neoadjuvant therapy.
Time frame
From the start of the first neoadjuvant treatment to four weeks after the first tumor assessment.2
The rate of pathological complete response (pCR)
Pathological Complete Response (pCR) refers to the absence of any residual cancer cells in the tumor tissue resected after neoadjuvant therapy.
Time frame
Through study completion, an average of 1 year3
Event free survival (EFS)
Event-Free Survival (EFS) refers to the time from the start of treatment to the first occurrence of disease progression, recurrence, death, or other predefined adverse events.
Time frame
From the start of the first neoadjuvant treatment, the observation period is up to 2 years.4
Overall survival (OS)
Overall Survival (OS) refers to the time from the start of treatment to the patient's death from any cause.
Time frame
From the start of the first neoadjuvant treatment, the observation period is up to 2 years.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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