Actively Recruiting
Goal-directed Enteral Nutritional Perioperative Management
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-07-19
400
Participants Needed
17
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Goal-directed Enteral Nutritional Perioperative Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-80 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Nutritional Risk Screening (NRS) 2002 score of 3 or higher
- Diagnosed with malnutrition using the GLIM criteria
- Histopathological confirmation of esophageal squamous cell carcinoma
- Primary tumor located in the thoracic esophagus
- Resectable locally advanced disease with clinical stage II to IVA as evaluated by a multidisciplinary team
- Receiving neoadjuvant therapy including chemotherapy, radiotherapy, immunotherapy, or combinations before surgery
- Provided informed consent for randomization and study protocol completion
You will not qualify if you...
- Nutritional Risk Screening (NRS) 2002 score below 3
- Undergoing upfront surgery without neoadjuvant treatment
- Any comorbidity interfering with digestion or absorption of ORAL IMPACT®
- Receiving other nutritional support during the study
- Unable to consume nutrition orally or via tube feeding before surgery
- History of other malignancies in the past 5 years except basal-cell skin carcinoma or cervical tumors in situ
- Severe liver or kidney dysfunction (ALT, total bilirubin, or creatinine levels at or above twice the upper limit of normal)
- Metabolic disorders including uncontrolled diabetes (fasting blood glucose ≥10 mmol/L), hypothyroidism, or hyperthyroidism
- Receiving fat emulsions with Omega-3, glutamine, thymosin, glucocorticoids, thyroxine, growth hormone, or anti-tumor necrosis factor biologics
- Known allergy to any component of ORAL IMPACT®
- Pregnant or lactating women, or women of childbearing potential without reliable contraception
- Refusal to consent or inability to follow the study protocol
- Judged inappropriate to participate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Daping Hospital, Third Affiliated Hospital of Third Military Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
3
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
4
Anyang Cancer Hospital
Anyang, Henan, China
Actively Recruiting
5
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
6
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
7
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Actively Recruiting
8
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Actively Recruiting
9
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Actively Recruiting
10
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
11
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
12
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
13
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
14
Changzhi People's Hospital
Changzhi, Shanxi, China
Actively Recruiting
15
Shanxi Cancer Hospital, Chinese Academy of Medical Sciences
Taiyuan, Shanxi, China
Actively Recruiting
16
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
17
Yunnan Cancer Hospital
Kunming, Yunnan, China
Actively Recruiting
Research Team
X
Xiaozheng Kang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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