Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06510543

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-07-19

400

Participants Needed

17

Research Sites

247 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether goal-directed nutritional therapy during the perioperative period can prevent postoperative lung and other serious complications in malnourished patients with esophageal squamous cell cancer. The study aims to determine if individualized nutrition support improves short-term surgical outcomes and long-term survival compared to conventional nutritional therapy. This is a multicenter, open-label, randomized controlled trial focused on esophageal cancer patients at nutritional risk. Participants are randomly assigned to receive either supervised goal-directed enteral nutritional therapy, which includes homemade meals with or without ORAL IMPACT® tailored to daily energy goals, or conventional unsupervised enteral nutritional support without ORAL IMPACT®. The study compares these two nutritional approaches during the perioperative period, with neoadjuvant therapies allowed before surgery. During the study, researchers monitor rates of postoperative lung complications, unplanned hospital and ICU admissions, nutritional status markers like serum prealbumin and body mass index, and treatment-related adverse events up to three months after surgery. They also evaluate overall survival and disease-free survival over five years, along with health-related quality of life. Participants are followed closely to assess safety and effectiveness of the nutritional strategies.

CONDITIONS

Brief Title

Goal-directed Enteral Nutritional Perioperative Management

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-80 years old
  • ECOG performance status 0 to 1
  • Nutritional risk score (NRS 2002) of 3 or higher
  • Malnutrition diagnosed by GLIM criteria
  • Histopathological confirmation of esophageal squamous cell carcinoma
  • Primary tumor located in the thoracic esophagus
  • Resectable locally advanced disease, clinical stage II to IVA
  • Planned neoadjuvant therapy including chemo-radiotherapy, chemotherapy, or immunotherapy
  • Provided informed consent and able to complete the study protocol
Not Eligible

You will not qualify if you...

  • Nutritional risk score (NRS 2002) less than 3
  • Surgery planned without neoadjuvant treatment
  • Any condition interfering with digestion or absorption of ORAL IMPACT®
  • Receiving other nutritional support during the study
  • Unable to consume nutrition orally or via tube feeding before surgery
  • History of other cancers within past 5 years except certain skin or cervical tumors
  • Severe liver or kidney function abnormalities
  • Uncontrolled metabolic disorders like diabetes or thyroid diseases
  • Receiving certain medications including Omega-3 emulsions, glutamine, thymosin, glucocorticoids, thyroxine, growth hormone, or anti-tumor necrosis factor agents
  • Known allergy to any component of ORAL IMPACT®
  • Pregnant or lactating women, or women not using reliable contraception
  • Refusal or inability to follow study protocol
  • Judged unsuitable for participation by investigators

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - From randomization through 3 months after surgery

Participants receive individualized perioperative enteral nutritional therapy guided by daily energy targets or conventional enteral nutritional therapy during the perioperative period.

Visits occur throughout the perioperative period and up to 3 months post-surgery

Follow-up

Duration - Up to 5 years after randomization

Participants are monitored for overall survival, disease-free survival, and long-term outcomes up to five years post-randomization.

Periodic follow-up visits up to 5 years

Trial Site Locations

Total: 17 locations

1

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

2

Daping Hospital, Third Affiliated Hospital of Third Military Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

3

Fujian Cancer Hospital

Fuzhou, Fujian, China

Actively Recruiting

4

Anyang Cancer Hospital

Anyang, Henan, China

Actively Recruiting

5

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

6

Henan Cancer Hospital

Zhengzhou, Henan, China

Actively Recruiting

7

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Actively Recruiting

8

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Actively Recruiting

9

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Actively Recruiting

10

Qilu Hospital of Shandong University

Jinan, Shandong, China

Actively Recruiting

11

Shandong Provincial Hospital

Jinan, Shandong, China

Actively Recruiting

12

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

13

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Actively Recruiting

14

Changzhi People's Hospital

Changzhi, Shanxi, China

Actively Recruiting

15

Shanxi Cancer Hospital, Chinese Academy of Medical Sciences

Taiyuan, Shanxi, China

Actively Recruiting

16

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

17

Yunnan Cancer Hospital

Kunming, Yunnan, China

Actively Recruiting

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Research Team

X

Xiaozheng Kang, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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