Preoperative nutrition for esophageal cancer patients undergoing treatment
Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy
This study is testing if a special immune-boosting diet before surgery can help people with esophageal cancer recover better and have fewer problems after their treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 6 sites (Shanghai, Shanghai Municipality and 5 other locations) |
| Trial ID | NCT04513418 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effects of preoperative enteral immunonutrition in patients with esophageal cancer who are receiving neoadjuvant therapy. The study aims to determine if an immune-modulating diet before surgery can reduce complications and improve perioperative outcomes. It involves a sample size of 206 participants, with a 2:1 ratio of intervention to control groups, to assess the impact of nutritional support on postoperative recovery. The trial is designed to address the controversy surrounding preoperative nutritional support in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed esophageal cancer who are scheduled for neoadjuvant therapy and have a BMI of at least 18.5.
Not a fit: Patients with complete dysphagia or serious co-morbidities that prevent them from tolerating neoadjuvant therapy or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for esophageal cancer patients.
How similar studies have performed: Other studies have shown promising results with nutritional interventions in postoperative recovery, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed esophageal cancer * Staging as cT2N0M0 with high-risk lesions (lymphovascular invasion, ≥3cm, poorly differentiated) / cT1b-2N+M0 / cT3-4aN0-3M0 with the need of neoadjuvant therapy before radical esophagectomy * Tolerance with oral intake (at least fluid diet) * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Body Mass Index (BMI) ≥ 18.5 kg/m2 before recruitment * Patient's approval and written informed consent Exclusion Criteria: * Expected survival time less than 6 months * Complete dysphagia * Pregnant or breast-feeding women * Unable to obey the interventions because of any reasons * Serious co-morbidities (cardiac, pulmonary, liver, kidney, brain, hematologic, endocrine and other diseases) in patients who cannot tolerate neoadjuvant therapy and/or surgery * History of previous thoracic or abdominal surgery * History of other malignant tumor (previous or current) * Patients with primary small cell carcinoma of the esophagus
Where this trial is running
Shanghai, Shanghai Municipality and 5 other locations
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhongshan Hospital Affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
- Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Hecheng Li, PhD, MD — Ruijin Hospital
- Study coordinator: Hecheng Li, PhD, MD
- Email: lihecheng2000@hotmail.com
- Phone: 00862164370045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.