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New treatment option for Esophagus Cancer
Official title Goal-directed Enteral Nutritional Perioperative Management
ClinicalTrials.gov ID: NCT06510543
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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;
You likely can't join if
- NRS 2002 score \< 3;
- Upfront surgery without neoadjuvant treatment;
- Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
- Receiving any other nutritional support during the study;
- Unable to consume nutrition orally or receive it through tube feeding before surgery;
- History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
See the full eligibility criteria
- 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.
- NRS 2002 score \< 3;
- Upfront surgery without neoadjuvant treatment;
- Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
- Receiving any other nutritional support during the study;
- Unable to consume nutrition orally or receive it through tube feeding before surgery;
- History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
- 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;
- Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
- History of known allergy to any component 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Anyang, Henan, China
- Zhengzhou, Henan, China
- Huai'an, Jiangsu, China
- Nanjing, Jiangsu, China
- Jinan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Changzhi, Shanxi, China
- Taiyuan, Shanxi, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China; Anyang, Henan, China; Zhengzhou, Henan, China; Huai'an, Jiangsu, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.