RecruitingNot ApplicableNCT06510543

Goal-directed Enteral Nutritional Perioperative Management

Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

400 participants

Start Date

Mar 30, 2024

Study Type

INTERVENTIONAL

Conditions

Esophagus Cancer

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a carefully tailored tube-feeding (enteral nutrition) program, started before and continued after surgery, improves outcomes for patients with esophageal squamous cell cancer who are malnourished and scheduled to undergo neoadjuvant therapy followed by surgery. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with esophageal squamous cell carcinoma located in the chest portion of the esophagus - Your cancer is at a locally advanced but potentially resectable stage (clinical stage II–IVA) - You are malnourished based on a standard nutritional assessment - You are scheduled to receive neoadjuvant (pre-surgery) treatment followed by surgery - You are in good functional status (ECOG 0–1) **You may NOT be eligible if...** - Your cancer cannot be surgically removed - You are not malnourished based on assessment - You have severe heart, liver, kidney, or other organ problems that prevent surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTGoal-directed EN therapy

The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.

DIETARY_SUPPLEMENTConventional EN therapy

The participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).

Locations(17)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Daping Hospital, Third Affiliated Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Anyang Cancer Hospital

Anyang, Henan, China

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Provincial Hospital

Jinan, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Changzhi People's Hospital

Changzhi, Shanxi, China

Shanxi Cancer Hospital, Chinese Academy of Medical Sciences

Taiyuan, Shanxi, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

View Full Details on ClinicalTrials.gov

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NCT06510543

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