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Comprehensive Nutritional Therapy for Potentially Resectable Locally Advanced Esophageal Carcinoma

The Impact of Comprehensive Nutritional Therapy on Clinical Outcomes in Patients with Potentially Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective, Randomized, Open-Label, Blinded Endpoint Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102235
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Potentially Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

Comprehensive Nutrition Group:Patients received daily oral supplementation with enteral nutrition formula (Nutricia, Netherlands
500 kcal/day) in addition to a regular diet from the initial hospitalization throughout neoadjuvant therapy. Intraoperative placement of a nasojejunal tube or jejunostomy was performed. Postoperativel
Neoadjuvant Nutrition Group:Patients followed identical inpatient protocols to the Comprehensive Nutrition Group from initial hospitalization until discharge. Following discharge criteria fulfillment,
Conventional Nutrition Group:Patients main

Sponsors

Jinling Hospital, Medical School of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary informed consent signed; able to objectively describe symptoms, no severe infections/respiratory insufficiency, and cooperative. 2. Age >=20 and <=80 years, regardless of gender. 3. Histopathologically confirmed esophageal carcinoma via endoscopic biopsy. 4. Clinical stage cT1b-2N+ or cT3-4aNanyM0, requiring preoperative neoadjuvant chemoradiotherapy (nCRT) as determined by multidisciplinary team (MDT) evaluation. 5. Initial nutritional assessment score <=3 on the Patient-Generated Subjective Global Assessment (PG-SGA) (no or mild malnutrition). 6. Absence of contraindications to nCRT or subsequent surgery. 7. Ability to adhere to prescribed medication regimens and follow-up schedules. 8. Non-pregnant and non-lactating females.

Exclusion criteria

Exclusion criteria: 1. Failure to meet inclusion criteria or deemed unsuitable for participation by principal investigator 2. Metabolic disorders (e.g., diabetes mellitus, thyroid dysfunction) or severe comorbidities affecting cardiac, hepatic, pulmonary, renal, or neurological systems 3. Weight loss =10% within 6 months, BMI <18.5 kg/m^2, Subjective Global Assessment (SGA) grade C, or serum albumin <30 g/L without hepatic/renal dysfunction 4. Major postoperative complications (e.g., significant hemorrhage, reoperation) 5. Participation in any investigational drug trials (including the study drug in this trial) within 3 months prior to enrollment 6. Allergic constitution/history of anaphylaxis to study drugs/anesthetics. 7. History of hypersensitivity to study drug components, structurally related compounds, or anesthetic agents; allergic predisposition 8. Incomplete study-related documentation during follow-up.

Design outcomes

Primary

MeasureTime frame
PG-SGA;EORTC QLQ-C30;

Secondary

MeasureTime frame
Weight ;Survival time;

Countries

China

Contacts

Public ContactYi Shen

Jinling Hospital, Medical School of Nanjing University

dryishen@nju.edu.cn+86 139 1390 7880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026