Goal-directed Enteral Nutritional Perioperative Management

Last updated: July 14, 2024
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Digestive System Neoplasms

Esophageal Disorders

Treatment

Conventional EN therapy

Goal-directed EN therapy

Clinical Study ID

NCT06510543
GENTLEMAN
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 editionUICC/AJCC) evaluated by a multidisciplinary team;

  8. Neoadjuvant therapy will be administered, which may entail preoperativechemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such asanti-PD-1/PD-L1;

  9. Informed consent for random assignment and completion of the protocol.

Exclusion

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 beforesurgery;

  6. History of other malignancies in the past 5 years, except successfully treatedbasal-cell skin carcinoma and cervical tumors in situ;

  7. Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit ofnormal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit ofnormal);

  8. Metabolic disorders, including uncontrolled diabetes mellitus or fasting bloodglucose ≥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 biologicagents

  10. History of known allergy to any component of ORAL IMPACT®;

  11. Pregnant or lactating women, women of childbearing potential with either a positivepregnancy test at baseline or not using a reliable and appropriate contraceptivemethod;

  12. Refuse to sign the consent or unable to follow the study protocol;

  13. Inappropriate to participate in this study judged by investigators.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Conventional EN therapy
Phase:
Study Start date:
March 30, 2024
Estimated Completion Date:
May 30, 2031

Study 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.

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Daping Hospital, Third Affiliated Hospital of Third Military Medical University

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Anyang Cancer Hospital

    Anyang, Henan
    China

    Active - Recruiting

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Huai'an First People's Hospital

    Huai'an, Jiangsu
    China

    Active - Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Changzhi People's Hospital

    Changzhi, Shanxi
    China

    Active - Recruiting

  • Shanxi Cancer Hospital, Chinese Academy of Medical Sciences

    Taiyuan, Shanxi
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan
    China

    Active - Recruiting

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