Nutritional therapy for esophageal cancer patients during surgery

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 investigates the effectiveness of goal-directed nutritional therapy in preventing postoperative complications in malnourished patients with esophageal squamous cell cancer. It compares individualized nutritional support to conventional methods to assess impacts on surgical outcomes and long-term survival. The study is a multicenter, open-label, randomized, controlled phase 3 trial, focusing on major complications within 90 days post-surgery and evaluating nutritional status and overall survival. The aim is to enhance recovery and quality of life through tailored nutritional interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18-80 years old;
2. ECOG PS 0\~1;
3. NRS 2002 score ≥3;
4. Malnutrition diagnosed according to the GLIM criteria;
5. Histopathologically confirmed as esophageal squamous cell carcinoma;
6. Primary tumors located in thoracic esophagus;
7. Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team;
8. Neoadjuvant therapy will be administered, which may entail preoperative chemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such as anti-PD-1/PD-L1;
9. Informed consent for random assignment and completion of the protocol.

Exclusion Criteria:

1. NRS 2002 score \< 3;
2. Upfront surgery without neoadjuvant treatment;
3. Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
4. Receiving any other nutritional support during the study;
5. Unable to consume nutrition orally or receive it through tube feeding before surgery;
6. History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
7. Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit of normal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit of normal);
8. Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
9. Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
10. History of known allergy to any component of ORAL IMPACT®;
11. Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test at baseline or not using a reliable and appropriate contraceptive method;
12. Refuse to sign the consent or unable to follow the study protocol;
13. Inappropriate to participate in this study judged by investigators.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Daping Hospital, Third Affiliated Hospital of Third Military Medical University
  Chongqing, Chongqing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• Anyang Cancer Hospital
  Anyang, Henan, China Recruiting
• First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting

Study contacts

• Principal investigator: Yin Li, M.D. — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Xiaozheng Kang, M.D.
• Email: kangxz@cicams.ac.cn
• Phone: +86 13910052790

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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.