Trial Title:
Goal-directed Enteral Nutritional Perioperative Management
NCT ID:
NCT06510543
Condition:
Esophagus Cancer
Conditions: Official terms:
Esophageal Neoplasms
Conditions: Keywords:
Esophageal Cancer
Esophagectomy
Nutritional Therapy
Morbidity
Survival
Malnourished
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Goal-directed EN therapy
Description:
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.
Arm group label:
Goal-directed enteral nutritional therapy
Intervention type:
Dietary Supplement
Intervention name:
Conventional EN therapy
Description:
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).
Arm group label:
Conventional enteral nutritional therapy
Summary:
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.
Detailed description:
Severe malnutrition is a significant risk factor for postoperative complications in
esophageal cancer patients. Early oral nutritional supplementation after surgery can
prevent weight loss and improve quality of life. The EFFORT trial showed that
individual-based enteral nutrition support reduced complications, extended 1-year
survival, and improved quality of life. This study aims to assess the safety and
effectiveness of individualized perioperative nutrition support guided by daily energy
targets in esophageal cancer patients at nutritional risk. It also seeks to determine if
supplementing immunonutrition can effectively reduce postoperative complications. This
study was conducted as a multicenter, open-label, randomized, controlled phase 3 trial.
The experiment group was administered goal-directed enteral nutritional therapy, while
the control group received conventional enteral nutritional therapy. The study observed
the participants' major pulmonary and other complications within 90 days post-surgery and
nutritional status, disease-free survival (DFS), and overall survival (OS) in both
groups.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yin Li, M.D.
Phone:
+86 (010) 87788052
Email:
liyin@cicams.ac.cn
Facility:
Name:
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Guo, M.D.
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuoyan Liu, M.D.
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Anlin Hao, M.D.
Facility:
Name:
First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiangnan Li, M.D.
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yan Zheng, M.D.
Facility:
Name:
Huai'an First People's Hospital
Address:
City:
Huai'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianqiang Zhao, M.D.
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Jiang, M.D.
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinhua Luo, M.D.
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Li, M.D.
Facility:
Name:
Shandong Provincial Hospital
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Zhang, M.D.
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhigang Li, M.D.
Facility:
Name:
Zhongshan Hospital Affiliated to Fudan University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Lijie Tan, M.D.
Facility:
Name:
Changzhi People's Hospital
Address:
City:
Changzhi
Country:
China
Status:
Recruiting
Contact:
Last name:
Changhong Lian, M.D.
Facility:
Name:
Shanxi Cancer Hospital, Chinese Academy of Medical Sciences
Address:
City:
Taiyuan
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianhong Lian, M.D.
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Tang, M.D.
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Guangqiang Zhao, M.D.
Start date:
March 30, 2024
Completion date:
May 30, 2031
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06510543
