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Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.

Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study. - DiCON study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026705
Enrollment
40
Registered
2017-05-01
Start date
2017-07-25
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

advanced esophageal and gastric cancer

Interventions

only Diet Counseling administration ONS once a day for 14 days administration ONS twice a day for 14 days administration ONS three times a day for 14 days

Sponsors

Cancer Institute Hospital Gastroenterological Chemotherapy Department
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)advanced gastric cancer or esophageal cancer 2)patients who plans 1st line chemotherapy or chemoradiotherapy 3)patients who can eat more than 50% 4)An age of over 20 5)PS ECOG performance status score 0-1 6)Major organs are in normal conditions in 14 days of administration neutrophil count => 1,500/mm3 Hemoglobin => 8.0g/dL Platelet count => 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST<=100 IU/L ALP<=100 IU/L Serum creatinine <= 2.0 mg/dL Written informed consent must be taken by patients

Exclusion criteria

Exclusion criteria: 1)ileus or subileus symptom 2)Active infectious diseases(except local infection) 3)massive ascites 4)weight loss more than 10% 5)plans triplet chemotherapy for 1st line chemotherapy 6)allergy for ONS 7)Uncontrollable DM 8)Pregnant or lactation women, or women with the possibility of the pregnancy 9)need systemic steroid therapy 10)Severe mental disorders, neurological disease 11)Dementia 12)Patients who are judged inappropriate for the entry into this study by the investigator

Design outcomes

Primary

MeasureTime frame
Changes in the ratio of prealbumin before and after administration of ONS

Secondary

MeasureTime frame
Compliance of ONS, Changes in the ratio of various nutritional index before and after administration of ONS

Countries

Japan

Contacts

Public ContactYukiko Izawa

Cancer Institute Hospital Department of Nutrition

yukiko.izawa@jfcr.or.jp03-3520-0111

Outcome results

None listed

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