Nutritional management for patients with esophageal cancer

Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy

This study tests if a personalized nutrition plan helps people with esophageal cancer feel better and manage their weight compared to standard nutrition advice.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05800054 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed stage II-III esophageal squamous cell carcinoma who are not undergoing surgical treatment.

Not a fit: Patients with distant organ metastasis or those who do not meet the specified health criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the nutritional status and overall quality of life for patients undergoing treatment for esophageal cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown that nutritional management can positively impact treatment outcomes in cancer patients.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

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

Study contacts

• Study coordinator: Xiaolin Ge, PhD

Conditions Esophageal Neoplasms; Adverse Drug Event