Clinical trial NCT06510543: Goal-directed Enteral Nutritional Perioperative Management
Official title: Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophagus Cancer
Keywords: Esophageal Cancer
Esophagectomy
Nutritional Therapy
Morbidity
Survival
Malnourished
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Severe malnutrition is a significant risk factor for postoperative complications in esophageal cancer patients. Early oral nutritional supplementation after surgery can prevent weight loss and improve quality of life. The EFFORT trial showed that individual-based enteral nutrition support reduced complications, extended 1-year survival, and improved quality of life. This study aims to assess the safety and effectiveness of individualized perioperative nutrition support guided by daily energy targets in esophageal cancer patients at nutritional risk. It also seeks to determine if supplementing immunonutrition can effectively reduce postoperative complications. This study was conducted as a multicenter, open-label, randomized, controlled phase 3 trial. The experiment group was administered goal-directed enteral nutritional therapy, while the control group received conventional enteral nutritional therapy. The study observed the participants' major pulmonary and other complications within 90 days post-surgery and nutritional status, disease-free survival (DFS), and overall survival (OS) in both groups.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-80 years old;
2. ECOG PS 0\~1;
3. NRS 2002 score ≥3;
4. Malnutrition diagnosed according to the GLIM criteria;
5. Histopathologically confirmed as esophageal squamous cell carcinoma;
6. Primary tumors located in thoracic esophagus;
7. Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC/AJCC) evaluated by a multidisciplinary team;
8. 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;
9. Informed consent for random assignment and completion of the protocol.

Exclusion Criteria:

1. NRS 2002 score \< 3;
2. Upfront surgery without neoadjuvant treatment;
3. Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;
4. Receiving any other nutritional support during the study;
5. Unable to consume nutrition orally or receive it through tube feeding before surgery;
6. History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;
7. 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);
8. Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol/L, hypothyroidism, or hyperthyroidism;
9. Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents
10. History of known allergy to any component of ORAL IMPACT®;
11. 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;
12. Refuse to sign the consent or unable to follow the study protocol;
13. Inappropriate to participate in this study judged by investigators.

Primary outcomes:
measure: Rate of postoperative pulmonary complications
timeFrame: Randomization to three months after surgery
measure: Rate of unplanned hospital admissions
timeFrame: Randomization to three months after surgery
measure: Rate of unplanned ICU admission
timeFrame: Randomization to three months after surgery
measure: Overall survival
timeFrame: Randomization to five years
Secondary outcomes:
measure: Rate of postoperative non-pulmonary complications
timeFrame: Randomization to three months after surgery
measure: Level of serum prealbumin
timeFrame: Randomization to three months after surgery
measure: Body mass index (BMI)
timeFrame: Randomization to three months after surgery
measure: Lean body mass
timeFrame: Randomization to three months after surgery
measure: Rate of treatment-related adverse events (TRAEs)
timeFrame: Randomization to three months after surgery
measure: Rate of R0 resection
timeFrame: Randomization to three months after surgery
measure: Rate of pathologic complete response (pCR)
timeFrame: Randomization to three months after surgery
measure: Disease-free survival (DFS)
timeFrame: Randomization to five years
measure: Scale of health-related quality of life (HRQOL)
timeFrame: Randomization to three months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Daping Hospital, Third Affiliated Hospital of Third Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Anyang
country: China
facility: Anyang Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
state: Shanghai
city: Changzhi
country: China
facility: Changzhi People's Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital, Chinese Academy of Medical Sciences
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yin Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: