Actively Recruiting
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Patients With Esophageal Cancer Undergoing Concurrent Chemoradiotherapy
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2023-04-05
210
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating nutritional management in patients with esophageal cancer undergoing concurrent chemoradiotherapy. This randomized, open, parallel controlled trial compares the effects of full-course nutritional support team (NST) intervention with routine nutrition guidance on body weight, body mass index (BMI), quality of life, nutritional status, immune function, inflammatory response, treatment side effects, and both short-term and long-term efficacy. The experimental group receives refined nutritional programs from nutritionists, including enteral and parenteral nutrition tailored to gastrointestinal status and dietary intake, with specific energy and protein targets. Nutritional supplements used include whole protein enteral nutrition preparations Nengquan, tumor-specific Ruineng, and whey protein powder. Radiotherapy and chemotherapy (Docetaxel and cisplatin) are given concurrently. The control group follows the same chemoradiotherapy and nutritional program but manages nutrition independently without NST support. Participants undergo regular assessments including body weight and BMI measurements, quality of life questionnaires (EORTCQLQ-C30), nutritional status checks, immune and inflammatory markers (total lymphocytes, CRP, IL-6), intestinal mucosal and flora evaluations, and monitoring of adverse reactions. The primary outcome is body weight and BMI changes over up to 3 years. Secondary outcomes include quality of life, hemoglobin, serum albumin, objective response rate, and long-term treatment effects. The study involves ongoing monitoring and data collection for up to 3 years.
CONDITIONS
Brief Title
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent with good compliance to treatment and follow-up
- Age between 18 and 75 years, any gender
- Confirmed esophageal squamous cell carcinoma by cytology or histology
- Stage II-III primary esophageal cancer treated non-surgically (except biopsy)
- Primary tumor evaluable with no distant organ metastasis
- PG-SGA nutritional risk score B (2-8) or C (≥9)
- Karnofsky Performance Status (KPS) score ≥ 70 and ECOG physical condition score 0-1
- Adequate major organ function within 7 days before treatment, including blood counts and biochemical tests within specified limits
- Expected survival of at least 6 months
You will not qualify if you...
- No malnutrition or nutritional risk (PG-SGA score A)
- Severely impaired intestinal function or intolerance to enteral nutrition
- Severe vomiting, gastrointestinal bleeding, or intestinal obstruction
- Very severe malnutrition preventing tolerance of chemoradiotherapy
- Prior radiotherapy, chemotherapy, or targeted therapy to primary tumor or lymph nodes
- Other malignancies within 5 years except cured cervical carcinoma in situ or basal cell carcinoma
- Participation in other drug trials within the past month
- Severe allergic history or idiosyncratic constitution
- History of severe lung or heart disease
- Serious uncontrolled comorbidities such as hypertension or heart failure
- Pregnant or breastfeeding women
- Current or planned participation in other clinical trials
- Refusal or inability to provide informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 to 9 weeks depending on chemoradiotherapy cycles
Participants undergo chemoradiotherapy alongside nutritional management. The experimental group receives nutritionist-formulated nutritional programs with refined management, including enteral or parenteral nutritional supplements, while the control group follows routine nutrition guidance independently. Radiotherapy is given using image-guided or intensity-modulated techniques, and chemotherapy includes Docetaxel and cisplatin administered concurrently.
Weekly visits for at least 2 cycles of chemoradiotherapy, with additional visits as needed
Duration - Up to 3 years
Participants are monitored for changes in body weight, body mass index, quality of life, nutritional status, immune function, inflammatory response, adverse reactions, and treatment efficacy for up to 3 years after treatment.
Periodic visits during the 3-year follow-up period
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
X
Xiaolin Ge, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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