Esophageal Neoplasms Clinical Trial
Official title:
Nutritional Route in Esophageal Resection Trial II (NUTRIENT II): a Randomized Controlled Trial
The aim of this study is to investigate the effects of early start versus delayed start of oral intake on postoperative functional recovery after an esophagectomy.
Early oral feeding is safe and beneficial in most types of gastro-intestinal surgery and is a
crucial part of fast track or enhanced recovery protocols. Following esophagectomy, fast
track programs are increasingly being applied, resulting in a reduced length of stay,
perioperative morbidity and hospital charges. In a previous feasibility study (Nutrient I
trial) has been shown that direct oral intake following esophagectomy was feasible and did
not result in an increase of major complications. It remains unclear what the best strategy
is for nutrition in the early postoperative phase following esophagectomy. The aim of this
study is to investigate the effects of early start versus delayed start of oral intake on
postoperative recovery and pulmonary complications following esophagectomy.
Patients will be recruited at the outpatient clinic of the Catharina Hospital Eindhoven and
the Hospital Group Twente.Patients will enroll in the early oral feeding group or the delayed
oral feeding group. The early oral feeding group will receive liquid oral nutrition directly
after surgery. Patients in the delayed oral feeding group will receive enteral tube feeding
(via a jejunostomy) for 5-7 days (standard protocol in The Netherlands). After these 5-7 days
a liquid oral diet is initiated.
Patient characteristics and clinical parameters are registered in an electronic database. All
surgical complications are classified using the Clavien-Dindo classification15 (Appendix II).
An independent investigator will check functional recovery daily. Data is provided by local
investigator via an online checklist (electronic case report form / website). Quality of life
and Symptoms are scored using the European organization for research and treatment of cancer
questionnaire (QLQ-C30/EORTC-OG25)16 at baseline (5 weeks after neoadjuvant treatment), 6
weeks, 3 months and 6 months postoperatively. Cost-effectiveness is scored via EQ-5D-5L, iMTA
Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ).
Nutritional status will be measured using the actual caloric and protein intake versus the
needed caloric and protein intake. Long-term outcome parameters such as local recurrence,
overall and cancer-specific survival will be registered in a database until the end of the
study.
The sample size calculation is based on functional recovery as primary outcome. Functional
recovery is the time to surgical recovery according to the definition described previously.
Patients in our historic cohort (1 week artificial nutrition) were at least considered
functional recovered by a mean of 12 days post-surgery. Patients in the NUTRIENT I were at
least functional recovered at day 10 postoperative (mean) following an esophagectomy. In this
trial we consider a reduction of 2 days in functional recovery as clinically significant.
Using a Power of 80%, an alpha of 5% and a standard deviation of 4 days, a total of 128
patients (64 patients in each group) is needed to show this difference. It is expected that
the primary outcome will not be normally divided and therefore an extra 15% inclusion is
necessary, requiring a total of 148 patients (74 patients in each group). Interim-analyses
will be performed following 50 and 100 patients and will be checked by an independent
physician.
All analyses will be done according to the intention-to-treat approach in which all
randomized patients are included, regardless of adherence to study protocol. Occurrences of
the primary and secondary endpoints are compared between the treatment groups. Results are
presented as risk ratios with corresponding 95% confidence intervals. A two-tailed P < 0.05
is considered statistically significant. To compare the groups the data will be tested for
normal distribution and an unpaired T-test will be performed when appropriate, otherwise the
Mann-Whitney U or Chi-square tests.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05013697 -
TQB2450 Solution for Injection (TQB2450)+Paclitaxel+Cisplatin ± Anlotinib in the Treatment of Esophageal Cancer.
|
Phase 2 | |
Completed |
NCT02128243 -
Trial of S-1 Maintenance Therapy in Metastatic Esophagogastric Cancer
|
Phase 2 | |
Completed |
NCT02253602 -
Innovative MRI Techniques to Improve Treatment Stratification of Patients With Esophageal Cancer
|
N/A | |
Completed |
NCT01900691 -
Removal of the Evolution® Esophageal Stent - Fully Covered
|
N/A | |
Completed |
NCT01719926 -
Phase I Platinum Based Chemotherapy Plus Indomethacin
|
Phase 1 | |
Terminated |
NCT01572987 -
Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus
|
N/A | |
Terminated |
NCT00760604 -
A Phase III Study of En Bloc Versus Non-En Bloc Esophagectomy in Esophageal Cancer
|
Phase 3 | |
Completed |
NCT00160030 -
Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer
|
Phase 2 | |
Suspended |
NCT00048529 -
Study of T900607-Sodium in Subjects With Previously Treated Gastric Cancer or Adenocarcinoma of the Esophagus
|
Phase 2 | |
Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
Completed |
NCT02284802 -
Early Detection of Tumors of the Digestive Tract by Confocal Endomicroscopy
|
N/A | |
Terminated |
NCT03223662 -
Metabolomic and BH3 Profiling of Esophageal Cancers: Identification of Novel Assessment Methods of Treatment Response for Precision Therapy
|
Phase 2 | |
Completed |
NCT05680077 -
KCNA3 and OTOP2 Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
|
||
Completed |
NCT03549494 -
Evaluation of Ocoxin®-Viusid® in Advanced Stomach Cancer and Gastric Esophagogastric Junction
|
Phase 2 | |
Completed |
NCT03261947 -
A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT00094978 -
Depsipeptide/Flavopiridol Infusion for Cancers of the Lungs, Esophagus, Pleura, Thymus or Mediastinum
|
Phase 1 | |
Recruiting |
NCT02908204 -
Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma
|
N/A | |
Completed |
NCT02703142 -
Endoscopic Evaluation After Esophagectomy
|
N/A | |
Recruiting |
NCT02604615 -
The Role of Different Cycles of Chemotherapy(Capecitabine-oxaliplatin) in Esophageal Chemoradiotherapy
|
Phase 3 | |
Active, not recruiting |
NCT02279134 -
Phase II/III Study Compare Adjuvant Chemoradiotherapy, Radiotherapy and Surgery Alone for Esophageal Carcinoma
|
Phase 2/Phase 3 |