The Intensive Nutritional Support in Esophageal Cancer Undergoing Neoadjuvant Therapy

NCT07067359 | Not Yet Recruiting DMC

• 1 other identifier: HX2023382
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with esophageal cancer undergoing neoadjuvant therapy were selected as research subjects for nutritional risk screening and malnutrition assessment. Patients identified with nutritional risk were randomized into the standard nutrition therapy group (SNT) and the intensive nutrition therapy group (INT). The surgical rate was evaluated in both groups of patients, and the effects of nutritional support therapy on nutritional status and quality of life were investigated.

Conditions

Esophageal Cancer

Keywords

Esophageal Cancer; nutrition; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Surgical resection rate

  The proportion of esophageal cancer patients who undergo radical surgical resection after neoadjuvant therapy.

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Objective response rate (ORR)

  From the start of the first neoadjuvant treatment to four weeks after the first tumor assessment.

• The rate of pathological complete response (pCR)

  Through study completion, an average of 1 year

• Event free survival (EFS)

  From the start of the first neoadjuvant treatment, the observation period is up to 2 years.

• Overall survival (OS)

  From the start of the first neoadjuvant treatment, the observation period is up to 2 years.

• Nutrition status

  Perioperative

Study Arms (2)

Intensive Nutrition therapy (INT)

EXPERIMENTAL

Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received dietary guidance and necessary nutritional supplements during hospitalization. In addition to this, they continued to receive ongoing nutritional counseling and monitoring after discharge to ensure sustained nutritional support.

Dietary Supplement: Enteral Nutrition

Standard Nutrition Therapy (SNT)

ACTIVE COMPARATOR

Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received a conventional nutritional support regimen during hospitalization, including dietary guidance and necessary nutritional supplements.

Dietary Supplement: Enteral Nutrition

Interventions

Enteral Nutrition DIETARY_SUPPLEMENT

This study selected patients with esophageal cancer undergoing neoadjuvant therapy as the research subjects. All enrolled patients underwent comprehensive nutritional risk screening and malnutrition assessment prior to enrollment. After the completion of nutritional risk screening and assessment, patients identified with nutritional risk were randomly assigned to two groups: the Standard Nutrition Therapy group (SNT) and the Intensive Nutrition Therapy group (INT). Patients in the SNT group received a conventional nutritional support regimen during hospitalization, which included dietary guidance and necessary nutritional supplements. In addition to the standard regimen, patients in the INT group continued to receive ongoing nutritional counseling and nutritional supplement support after discharge to ensure sustained nutritional support.

Also known as: Nutritional supplements, Dietary guidance

Intensive Nutrition therapy (INT); Standard Nutrition Therapy (SNT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Esophageal cancer；
• Patients were staged as cT1b-cT2N+M0 or cT3-cT4a, any N, M0. Based on the location of the tumor and clinical staging, they were defined as locally advanced resectable esophageal cancer；
• Patients planned for neoadjuvant therapy, with radical surgical resection intended after neoadjuvant treatment；
• Normal gastrointestinal function；
• PG-SGA score \>3;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2分.

You may not qualify if:

• Other tumors, including pancreatic cancer, liver cancer and other solid digestive tract tumors, colon cancer, rectal cancer and other tubular lower digestive tract tumors;
• Have serious heart, lung and brain diseases;
• Patients with unstable vital signs and multiple organ failure;
• The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires;
• Eastern Cooperative Oncology Group score \>2;
• The investigator believes that the subjects have a history of other serious systemic diseases or are not suitable for participating in this clinical study for other reasons

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Enteral Nutrition; Dietary Supplements

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Qing Li, PhD

CONTACT

+8618702848178; liqing@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Experimental: Intensive Nutrition therapy (INT) Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received dietary guidance and necessary nutritional supplements during hospitalization. In addition to this, they continued to receive ongoing nutritional counseling and monitoring after discharge to ensure sustained nutritional support. Active Comparator: Standard Nutrition Therapy (SNT) Esophageal cancer patients with nutritional risk undergoing neoadjuvant therapy received a conventional nutritional support regimen during hospitalization, including dietary guidance and necessary nutritional supplements.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: July 16, 2025
• Study Start: July 15, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07