Actively Recruiting
Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-07-19
400
Participants Needed
17
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether goal-directed nutritional therapy during the perioperative period can prevent postoperative lung and other serious complications in malnourished patients with esophageal squamous cell cancer. The study aims to determine if individualized nutrition support improves short-term surgical outcomes and long-term survival compared to conventional nutritional therapy. This is a multicenter, open-label, randomized controlled trial focused on esophageal cancer patients at nutritional risk. Participants are randomly assigned to receive either supervised goal-directed enteral nutritional therapy, which includes homemade meals with or without ORAL IMPACT® tailored to daily energy goals, or conventional unsupervised enteral nutritional support without ORAL IMPACT®. The study compares these two nutritional approaches during the perioperative period, with neoadjuvant therapies allowed before surgery. During the study, researchers monitor rates of postoperative lung complications, unplanned hospital and ICU admissions, nutritional status markers like serum prealbumin and body mass index, and treatment-related adverse events up to three months after surgery. They also evaluate overall survival and disease-free survival over five years, along with health-related quality of life. Participants are followed closely to assess safety and effectiveness of the nutritional strategies.
CONDITIONS
Brief Title
Goal-directed Enteral Nutritional Perioperative Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-80 years old
- ECOG performance status 0 to 1
- Nutritional risk score (NRS 2002) of 3 or higher
- Malnutrition diagnosed by GLIM criteria
- Histopathological confirmation of esophageal squamous cell carcinoma
- Primary tumor located in the thoracic esophagus
- Resectable locally advanced disease, clinical stage II to IVA
- Planned neoadjuvant therapy including chemo-radiotherapy, chemotherapy, or immunotherapy
- Provided informed consent and able to complete the study protocol
You will not qualify if you...
- Nutritional risk score (NRS 2002) less than 3
- Surgery planned without neoadjuvant treatment
- Any condition 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 cancers within past 5 years except certain skin or cervical tumors
- Severe liver or kidney function abnormalities
- Uncontrolled metabolic disorders like diabetes or thyroid diseases
- Receiving certain medications including Omega-3 emulsions, glutamine, thymosin, glucocorticoids, thyroxine, growth hormone, or anti-tumor necrosis factor agents
- Known allergy to any component of ORAL IMPACT®
- Pregnant or lactating women, or women not using reliable contraception
- Refusal or inability to follow study protocol
- Judged unsuitable for participation by investigators
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From randomization through 3 months after surgery
Participants receive individualized perioperative enteral nutritional therapy guided by daily energy targets or conventional enteral nutritional therapy during the perioperative period.
Visits occur throughout the perioperative period and up to 3 months post-surgery
Duration - Up to 5 years after randomization
Participants are monitored for overall survival, disease-free survival, and long-term outcomes up to five years post-randomization.
Periodic follow-up visits up to 5 years
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.
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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