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Oral nutritional supplements for the increase of oral caloric intake after gastrectomy: a single-arm prospective study

Oral nutritional supplements for the increase of oral caloric intake after gastrectomy: a single-arm prospective study - Oral nutritional supplements after gastrectomy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045645
Enrollment
50
Registered
2021-10-08
Start date
2021-11-15
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

gastric cancer

Interventions

Oral intake of oral nutrition (ENORAS 187.5ml/pack) will be started within 3 days of the start of postoperative meals and continued until postoperative day 90. The dosage may be increased or decreased
s subjective symptoms, etc., within the range of up to 3 packs/day (562.5 ml/day). The dosage may be increased or decreased at the discretion of the patient.

Sponsors

Niigata University
Lead Sponsor
Niigata Cancer Center Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients with histologically confirmed gastric cancer (2) Patients planned to undergo radical gastrectomy (3) Patients without distant metastasis (4) Patients aged between 20 and 80 years at the time of enrollment (5) Patients with a PS (ECOG) of 0 or 1 (6) Patients with preserved major organ function according to clinical examination within 14 days prior to enrollment (7) A patient whose written informed consent has been obtained

Exclusion criteria

Exclusion criteria: (1) Patients with carcinoma in the remnant stomach after gastrectomy (2) Patients with active multiple cancers (3) Patients with serious comorbidities (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes or hypertension, heart failure, renal failure, liver cirrhosis, liver failure, etc.) (4) Patients with allergies to oral nutritional supplements (5) Patients on warfarin medication (6) Patients with lactose intolerance (7) Patients with medical electrical devices such as pacemakers and implantable cardiac defibrillators (8) Patients with motor disorders of the upper or lower limbs due to orthopedic or neurological diseases, etc. (9) Patients who are judged unsuitable for the study by the principal investigator or sub-investigator

Design outcomes

Primary

MeasureTime frame
Proportion of patients who took an average of 200 kcal/day or more of oral nutrition

Secondary

MeasureTime frame
Weight loss rate, fat loss rate, and gluten loss rate 3 months after surgery Weight loss rate, fat-free weight loss rate, and gluten reduction rate 1 year after surgery Evaluation of various types of nutrition (TP, Alb, T-Chol, Rine pellet count, etc.) Adverse events

Countries

Japan

Contacts

Public ContactHiroshi Ichikawa

Niigata University Graduate School of Medical and Dental Sciences Division of Digestive and General Surgery

hichikawa-nii@med.niigata-u.ac.jp025-227-2228

Outcome results

None listed

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