Phase
Condition
Digestive System Neoplasms
Esophageal Disorders
Treatment
Conventional EN therapy
Goal-directed EN therapy
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18-80 years old;
ECOG PS 0~1;
NRS 2002 score ≥3;
Malnutrition diagnosed according to the GLIM criteria;
Histopathologically confirmed as esophageal squamous cell carcinoma;
Primary tumors located in thoracic esophagus;
Resectable locally advanced disease with clinical stage II to IVA (8th editionUICC/AJCC) evaluated by a multidisciplinary team;
Neoadjuvant therapy will be administered, which may entail preoperativechemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such asanti-PD-1/PD-L1;
Informed consent for random assignment and completion of the protocol.
Exclusion
Exclusion Criteria:
NRS 2002 score < 3;
Upfront surgery without neoadjuvant treatment;
Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
Receiving any other nutritional support during the study;
Unable to consume nutrition orally or receive it through tube feeding beforesurgery;
History of other malignancies in the past 5 years, except successfully treatedbasal-cell skin carcinoma and cervical tumors in situ;
Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit ofnormal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit ofnormal);
Metabolic disorders, including uncontrolled diabetes mellitus or fasting bloodglucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin,glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologicagents
History of known allergy to any component of ORAL IMPACT®;
Pregnant or lactating women, women of childbearing potential with either a positivepregnancy test at baseline or not using a reliable and appropriate contraceptivemethod;
Refuse to sign the consent or unable to follow the study protocol;
Inappropriate to participate in this study judged by investigators.
Study Design
Study Description
Connect with a study center
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing 100021
ChinaActive - Recruiting
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, Chongqing
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
ChinaActive - Recruiting
Anyang Cancer Hospital
Anyang, Henan
ChinaActive - Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
ChinaActive - Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu
ChinaActive - Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
ChinaActive - Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
ChinaActive - Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
ChinaActive - Recruiting
Shandong Provincial Hospital
Jinan, Shandong
ChinaActive - Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai
ChinaActive - Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai
ChinaActive - Recruiting
Changzhi People's Hospital
Changzhi, Shanxi
ChinaActive - Recruiting
Shanxi Cancer Hospital, Chinese Academy of Medical Sciences
Taiyuan, Shanxi
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin
ChinaActive - Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan
ChinaActive - Recruiting

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