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A randomized phase II study to evaluate the prolonged home enteral nutrition for patients after curative esophagectomy

A randomized phase II study to evaluate the prolonged home enteral nutrition for patients after curative esophagectomy - Prolonged HEN

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000033125
Enrollment
80
Registered
2018-06-25
Start date
2018-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal cancer

Interventions

Supplemental home enteral nutrition (at least 300 kcal / day or more) is continued up to 8 weeks after curative esophagectomy, Supplemental home enteral nutrition (at least 300 kcal / day or more) is

Sponsors

Tohoku University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Primary lesions are all confined within the thoracic esophagus, 2) an esophageal epithelial malignancy, 3) Surgery approached from the neck, chest and abdomen, 4) R0 resection with D2 dissection, 5) Tube jejunostomy was constructed at the esophagectomy, 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

MeasureTime frame
Weight loss of more than 10% (24 weeks after surgery)

Secondary

MeasureTime frame
1) Change rate of QOL score, 2) Readmission rate, 3) Incidence of an adverse event (associated with home enteral nutrition), 4) Length of indwelling a feeding jejunostomy tube, 5) Adherence rate of protocol treatment

Countries

Japan

Contacts

Public ContactHiroshi Okamoto

Tohoku University Hospital Department of Surgery

hi-ok@surg.med.tohoku.ac.jp022-717-7214

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026