Esophageal cancer
Conditions
Interventions
Oral nutrition supplementation (at least 600 kcal / day or more) is continued up to the previous operation day for patients undergoing neoadjuvant chemotherapy for esophageal cancer.
Sponsors
Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) clinical stage IB, II or III (TNM 8th), 4) R0 resection with thoracoabdominal surgery, 5) adequate oral intake (Ogilvie's dysphagia score 0 or 1), 6) >20 and <80 y.o., 7) ECOG-PS 0 or 1, 8) No history of surgery for esophageal cancer, 9 ) No history of chemotherapy or radiotherapy, 10) a) WBC >2000 and <10000/mm3, b) PLT >50000/mm3, c) AST <100 IU/L, ALT <100IU/L, d) T-Bil <2.0 g/dl, e) Cre <1.5mg/dl, 11) Written consent
Exclusion criteria
Exclusion criteria: 1) BMI <17.0 or >30.0, 2) Excision of other organs excluding stomach or gall bladder, 3) Active double cancer, 4) Pregnancy or breast-feeding, 5) Psychosis or mental symptoms, 6) Systemic administration of steroids, 7) History of myocardial infarction or unstable angina, 8) Poorly controlled hypertension, 9) Poorly controlled diabetes, 10) Respiratory disease requiring sustained oxygen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change rate of CONUT score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change rate of QOL score, 2) Change rate of body weight, 3) Incidence of an adverse event (associated with oral nutrition supplementation), 4) Complete rate of neoadjuvant chemotherapy, 5) Incidence of postoperative complication, 6) Adherence rate of protocol treatment | — |
Countries
Japan
Contacts
Public ContactHiroshi Okamoto
Tohoku University Hospital Department of Surgery
Outcome results
None listed