Nutritional therapy for esophageal cancer patients during surgery

Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management

This study tests if personalized nutritional support during surgery can help malnourished patients with esophageal cancer recover better and avoid complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 17 sites (Beijing, Beijing Municipality and 16 other locations)
• Trial ID: NCT06510543 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are malnourished adults aged 18-80 with esophageal squamous cell carcinoma who are undergoing neoadjuvant therapy and have resectable locally advanced disease.

Not a fit: Patients who are not malnourished or those undergoing upfront surgery without neoadjuvant treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve survival rates for esophageal cancer patients.

How similar studies have performed: Previous studies, such as the EFFORT trial, have shown success with individualized nutritional support in improving outcomes for similar patient populations.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 16 other locations

• 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)
• Huai'an First People's Hospital — Huai'an, Jiangsu, China (Recruiting)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Zhongshan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Changzhi People's Hospital — Changzhi, Shanxi, China (Recruiting)
• Shanxi Cancer Hospital, Chinese Academy of Medical Sciences — Taiyuan, Shanxi, China (Recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Yunnan Cancer Hospital — Kunming, Yunnan, 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.

Conditions Esophagus Cancer; Esophageal Cancer; Esophagectomy; Nutritional Therapy; Morbidity; Survival; Malnourished