The effect of oral nutritional supplement (ONS) on the prognostic nutritional index (PNI) during neoadjuvant chemotherapy for gastric cancer

The effect of oral nutritional supplement (ONS) on the prognostic nutritional index (PNI) during neoadjuvant chemotherapy for gastric cancer - The effect of ONS on the PNI during neoadjuvant chemotherapy for gastric cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012598

Enrollment

Registered

2013-12-17

Start date

2013-09-01

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

gastric cancer

Interventions

In addition to a meal, an enteral nutrient (Racol&amp

#174

NF) is administered 3 times per day (600 kcal / day) from the first day of chemotherapy to one day before the operation.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically confirmed gastric cancer (2) cT2-cT4b tumors with two or more lymph node of greater than 8 mm in minor axes (3) No peritoneal metastasis with laparoscopic confirmation (4) An age of 20-80 (5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (6) Sufficient function of the liver, kidney and bone marrow (7) Sufficient oral intake (8) Written informed consent

Exclusion criteria

Exclusion criteria: (1) Body mass index of < 30 (2) Severe bowel obstruction (3) Short-bowel syndrome (4) Severe liver or renal dysfunction (5) Uncontrolled diabetes mellitus (6) Congenital amino acid abnormalities (7) Milk protein allergy or soy protein allergy (8) Electrolyte abnormalities (9) Pregnancy or insufficient contraception (10) Severe mental disease

Design outcomes

Primary

Measure	Time frame
The rate of patients with a decrease in the PNI during neoadjuvant chemotherapy	—

Secondary

Measure	Time frame
(1) Nutritional status (2) Body weight and body mass index (3) Performance status (4) Feasibility of neoadjuvant chemotherapy (5) Adverse events	—

Countries

Japan

Contacts

Public ContactTomoyoshi Takayama, MD

Nara Medical University Department of Surgery

t-taka@naramed-u.ac.jp0744-29-8863

Outcome results

None listed

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