Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy (POINT)
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| ClinicalTrials.gov Identifier: NCT04513418 |
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Recruitment Status :
Recruiting
First Posted : August 14, 2020
Last Update Posted : September 2, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Neoplasms | Dietary Supplement: Preoperative immunonutrition | Phase 4 |
Esophageal cancer ranks the fourth in mortality and the sixth in incidence among cancers in China according to the latest report of cancer epidemiology. Although the development of neoadjuvant therapy and radical esophagectomy have improved the prognosis of esophageal cancer patients, dysphagia and digestive tract reconstruction can cause malnutrition and infection-related complications. Postoperative enteral and parenteral nutrition have proved to be effective in improving outcomes after esophagectomy. However, whether to provide a preoperative nutritional support for patients with resectable esophageal cancer remains controversial.
This prospective randomized controlled trial will evaluate the effects of preoperative enteral immunonutrition in esophageal cancer patients undergoing neoadjuvant therapy. The purpose of this study is to determine whether preoperative immune-modulating diet before surgery can improve the rate of complications and other perioperative outcomes.
The sample size is estimated with the hypothesis that preoperative immunonutrition during the neoadjuvant therapy can reduce postoperative nutrition and immune-related complications after esophagectomy. According to the previously published articles, the required sample size of interventional and control arm (ratio=2:1) was calculated as 137 cases and 69 cases to detect the reduction in related complications from 50% to 30% based on a bilateral significance level (α) of 0.05 and a power of test (1-β) of 0.80. Considering an estimated drop rate of 15%, the minimum sample size of this study is 244 patients, 162 cases in the interventional group and 82 in the control group. After signing the informed consent, every eligible participant will be randomized into either group based on a computer-generated random number. Blinding will not be applied to patients and surgeons due to the difficulty in clinical practice but outcomes assessor will be masked.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 250 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy |
| Actual Study Start Date : | November 10, 2020 |
| Estimated Primary Completion Date : | December 2023 |
| Estimated Study Completion Date : | December 2028 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Interventional group
Patients receive omega-3 fatty-acid enriched enteral nutritional emulsion from the start of neoadjuvant chemoradiotherapy until surgery. Patients are meanwhile encouraged to intake 25-30kcal/kg through regular food.
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Dietary Supplement: Preoperative immunonutrition
Preoperative immunonutrition includes an omega-3 fatty-acid enriched enteral nutritional emulsion given by oral intake, nasogastric feeding tube or jejunostomy 600ml per day, lasting from the start of neoadjuvant chemoradiotherapy until surgery. Meanwhile, oral intake is encouraged to reach 25-30kcal/kg through regular food. |
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No Intervention: Control group
Patients are encouraged to intake 25-30kcal/kg through regular food without supplemental nutritional support before esophagectomy.
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- Rate of postoperative nutrition and immune-related complications [ Time Frame: Up to 30 days after surgery ]Rate of gastrointestinal complications (anastomotic leakage, gastrointestinal dysfunction), metabolic complications (electrolyte disturbances, liver or renal dysfunction) and infectious complications(wound infection, catheter-related infection, pneumonia, sepsis, or other infections requiring antibiotics).
- Completion rate of neoadjuvant therapy and esophagectomy [ Time Frame: 2-3 months before surgery ]
- Adverse events during neoadjuvant chemoradiotherapy [ Time Frame: 2-3 months before surgery ]
- Pathological complete response rate (pCR) [ Time Frame: 2-3 months before surgery ]
- Blood loss [ Time Frame: At operation day ]
- Duration of surgery [ Time Frame: At operation day ]
- Rate of surgery-related complications [ Time Frame: At operation day ]Conversion to open surgery, recurrent nerve injury, cardiac and cerebrovascular accident
- Length of hospital stay [ Time Frame: Postoperative in-hospital stay ]
- Hospitalization costs [ Time Frame: Postoperative in-hospital stay ]
- 30-day and 90-day mortality [ Time Frame: Up to 90 days after surgery ]
- Weight loss [ Time Frame: From neoadjuvant chemoradiotherapy to 6 months after surgery ]
- Perioperative change in PG-SGA score [ Time Frame: From neoadjuvant chemoradiotherapy to 6 months after surgery ]
- Perioperative change in blood pressure [ Time Frame: From neoadjuvant chemoradiotherapy to 6 months after surgery ]
- Perioperative change in biochemical indicators [ Time Frame: From neoadjuvant chemoradiotherapy to 6 months after surgery ]WBC, albumin, CRP, TNF-α, IL-6, IgA, IgG, IgM, insulin, C-peptide, glucose, hemoglobin, vitamin A, vitamin D, serum ferritin, transferrin receptor
- EORTC QLQ-C30 and OES-18 scale [ Time Frame: 1-year, 3-year, and 5-year after surgery ]Quality of life
- Long-term survival [ Time Frame: 1-year, 3-year, and 5-year after surgery ]Overall survival (OS) and progression-free survival (PFS)
- Daily dietary intake [ Time Frame: Through study completion, an average of 6 months ]24 hour meal review every week
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed esophageal cancer
- Staging as cT2-T3, N0-3, M0 with the need of neoadjuvant therapy before radical esophagectomy
- Tolerance for oral intake (at least fluid diet)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Body Mass Index (BMI) ≥ 18.5 kg/m2 before recruitment
- Patients approve and sign the 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04513418
| Contact: Hecheng Li, PhD, MD | 00862164370045 ext 664566 | lihecheng2000@hotmail.com | |
| Contact: Yuqin Cao, MD | 008613918933069 | caoyuqin314@163.com |
| China, Shanghai | |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting |
| Shanghai, Shanghai, China, 200011 | |
| Contact: Mingsong Wang 00862123271699 wangmingsong@xinhuamed.com.cn | |
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting |
| Shanghai, Shanghai, China, 200025 | |
| Contact: Dingpei Han, PhD, MD 00862164370045 ext 666112 dmhan1985@163.com | |
| Contact: Su Yang, MD 00862164370045 ext 666112 ys19851021@sina.com | |
| Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University | Not yet recruiting |
| Shanghai, Shanghai, China, 200030 | |
| Contact: Zhigang Li 00862122200000 zhigang_li_sch@163.com | |
| Zhongshan Hospital Affiliated to Fudan University | Not yet recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Lijie Tan 00862164041990 tan.lijie@zs-hospital.sh.cn | |
| China, Zhejiang | |
| Ningbo Medical Center Lihuili Hospital | Recruiting |
| Ningbo, Zhejiang, China, 315048 | |
| Contact: Weiyu Shen 0086057487018701 ningbomblhlswy@163.com | |
| Principal Investigator: | Hecheng Li, PhD, MD | Ruijin Hospital |
| Responsible Party: | Hecheng Li M.D., Ph.D, Professor, Ruijin Hospital |
| ClinicalTrials.gov Identifier: | NCT04513418 |
| Other Study ID Numbers: |
RTS-011 |
| First Posted: | August 14, 2020 Key Record Dates |
| Last Update Posted: | September 2, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Esophageal Neoplasms Neoadjuvant Therapy Enteral Nutrition Nutrition Therapy |
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Esophageal Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases |