Actively Recruiting
To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
Led by Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd · Updated on 2024-07-01
350
Participants Needed
14
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer undergoing surgical resection during the perioperative period.
CONDITIONS
Official Title
To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agreed to participate in the study with signed informed consent form
- Age between 18 and 75 years
- Confirmed gastrointestinal cancer by histological or imaging methods and scheduled for surgical resection (open or laparoscopic)
- No radiotherapy or chemotherapy within 2 weeks before screening
- Hemoglobin level of at least 90 g/L
- Albumin level of at least 2.5 g/dL
- Body mass index (BMI) between 18.5 and 29 kg/m2
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 before surgery
- Expected survival time greater than 6 months
You will not qualify if you...
- Contraindications or intolerance to enteral nutrition, such as acute gastrointestinal bleeding or severe ileus
- Any congenital defects affecting amino acid or carbohydrate metabolism, like phenylalaninemia or galactosaemia
- Conditions requiring emergency surgery
- Serious active infections (grade above 2), including active tuberculosis, HIV infection, or active hepatitis B or C
- Treatment-resistant metabolic diseases such as poorly controlled diabetes or thyroid disorders
- Severe heart problems (New York Heart Association class higher than III)
- Severe liver dysfunction with elevated liver enzymes or bilirubin
- Severe kidney dysfunction with high serum creatinine or requiring dialysis
- Active treatment-resistant bleeding
- Other cancers within the last 3 years except certain in situ skin or cervical tumors
- Diseases severely affecting digestion or absorption of study products
- History of drug or alcohol abuse within 6 months before screening
- Current use of high-dose fish oil or muscle growth supplements
- Planned chemotherapy, radiotherapy, or immunotherapy during first 12 days after surgery
- Blood transfusion within 1 week before screening
- Known allergy to study or control product contents
- Pregnancy or breastfeeding
- Participation in another clinical trial with investigational products within 1 month before or during study
- Inability to understand study information or unwillingness/inability to comply with study visits and requirements
- Investigator's judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Beijing Hospital
Beijing, China, 100730
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
3
Capital Medical University Affiliated Beijing Shijitan Hospital
Beijing, China
Actively Recruiting
4
Peking University People's Hospital
Beijing, China
Actively Recruiting
5
Xiangya Hospital Central South University
Changsha, China
Actively Recruiting
6
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, China
Actively Recruiting
7
Nanfang Hospital
Guanzhou, China
Actively Recruiting
8
Yunnan Cancer Hospital（The affiliated hospital of Kunming medical university）
Kunming, China
Actively Recruiting
9
Jiangsu Province Hospital of Chinese Medicine
Nanjing, China
Actively Recruiting
10
The Affiliated Hospital of Qingdao University
Qingdao, China
Actively Recruiting
11
The Fourth Hospital of Hebei Medical University （Hebei Tumor Hospital）
Shijia Zhuang, China
Actively Recruiting
12
The First Affiliated Hospital of SOOCHOW University
Suzhou, China
Actively Recruiting
13
The Central Hospital of Wuhan
Wuhan, China
Actively Recruiting
14
Union hospital tongji medical college huazhong university of science and technology
Wuhan, China
Actively Recruiting
Research Team
H
Haiwei Li
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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