Nutritional management for patients with esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial compares the effects of NST whole-course nutritional management against routine nutritional guidance in patients with esophageal cancer. It is a randomized, open, parallel controlled trial that assesses changes in body weight and BMI, as well as quality of life, nutritional status, immune function, inflammatory response, and adverse reactions to treatments like radiotherapy and chemotherapy. The experimental group receives tailored nutritional programs, including enteral or parenteral nutrition, based on individual dietary needs and treatment responses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Sign the informed consent; must have good compliance with the treatment plan and follow-up.
* No gender restriction, but age between 18 and 75 years old;
* Cytological or histological is confirmed esophageal squamous cell carcinoma;
* Non-surgical treatment of stage II-III primary esophageal cancer (except biopsy);
* The primary tumor can be evaluated;
* No distant organ metastasis;
* PG-SGA score B (2\~8) or C (≥9);
* KPS score ≥ 70 points, ECOG physical condition score 0-1 points;
* The function of major organs (bone marrow, liver, kidney function) 7 days before treatment, meet the following criteria: Blood routine examination standards (without blood transfusion within 14 days):

  * Hemoglobin (HB) ≥ 100g/L;

    * White blood cells (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥1.5×109/L;

      * Platelet (PLT) ≥ 100×109/L.
* The biochemical examination shall meet the following standards:

  * Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);

    * Alanine aminotransferase (ALT) and aspartate aminotransferase AST ≤ 1.5 times ULN;

      * Serum creatinine (Cr) ≤ 1.5 times ULN or creatinine clearance rate (CCr) ≥ 60ml/min.
* Expected survival ≥ 6 months.

Exclusion Criteria:

* No malnutrition or nutritional risk; PG-SGA score of A;
* Severely impaired intestinal function, or intolerance of enteral nutrition;
* Severe vomiting, gastrointestinal bleeding, intestinal obstruction;
* Patients with very severe malnutrition cannot tolerate radiotherapy and chemotherapy;
* The primary tumor or lymph node has received radiotherapy, chemotherapy or targeted therapy;
* Suffering from other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or skin basal cell carcinoma);
* Subjects who have received other drug trials within the past month;
* Those with severe allergic history or idiosyncratic constitution;
* Those with a history of severe lung or heart disease;
* Serious comorbidities, such as uncontrolled hypertension, heart failure, etc.;
* Pregnant or breastfeeding women;
* Currently or planning to participate in other clinical trials;
* Refusal or inability to sign the informed consent form to accept participation in the trial.

Where it's running

• The First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaolin Ge, PhD
• Email: doctorsxl@163.com
• Phone: 13951818797

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.