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RECRUITINGINTERVENTIONAL

Goal-directed Enteral Nutritional Perioperative Management

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.

Who May Be Eligible (Plain English)

Who May Qualify: 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. willing to sign a consent form for random assignment and completion of the protocol. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Goal-directed EN therapy

The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.

DIETARY_SUPPLEMENT

Conventional EN therapy

The participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).

Locations (17)

Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Anyang Cancer Hospital
Anyang, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Shanxi Cancer Hospital, Chinese Academy of Medical Sciences
Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China