NCT06510543Recruiting
Goal-directed Enteral Nutritional Perioperative Management
Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
Source: ClinicalTrials.gov · Last updated 19 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 18 Jun 2024
- Start date
- 30 Mar 2024
- Primary completion date
- 30 Aug 2026
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06510543
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 30 Mar 2024 to the primary completion date, 30 Aug 2026
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Upfront surgery without neoadjuvant treatment;
- Receiving any other nutritional support during the study;
- Unable to consume nutrition orally or receive it through tube feeding before surgery;
- Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
Other illness
- History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
- History of known allergy to any component of ORAL IMPACT®;
Lab values
- 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);
- Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
Other
- NRS 2002 score \< 3;
- Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
- 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;
- Refuse to sign the consent or unable to follow the study protocol;
- Inappropriate to participate in this study judged by investigators.
Who the study is looking for
- 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 edition UICC/AJCC) evaluated by a multidisciplinary team;
- 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;
- Informed consent for random assignment and completion of the protocol.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Cancer Hospital Coordinator of this site? Confirm its status | Anyang | China | Recruiting |
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Changzhi People's Hospital Coordinator of this site? Confirm its status | Changzhi | China | Recruiting |
| Daping Hospital, Third Affiliated Hospital of Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| Fujian Cancer Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| Jiangsu Cancer Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Jiangsu Provincial People's Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| Zhongshan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanxi Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.