The Effect of Immunonutrition and Chemotherapy Induced Neutropenia in Advanced Gastrointestinal Cancer Receiving Palliative Chemotherapy A Pilot Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20210723001

Enrollment

Registered

2021-07-23

Start date

2021-08-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Malnutrition in Advanced Gastrointestinal Cancer Receiving Palliative Chemotherapy advance gastrointestinal cancer, malnutrition

Interventions

Patients will receive Neomune (Immunonutrition) for 2 sachet/day (total calorie 500 kcal) /day for 3 months ,Patients will receive Blendera (Isocaloric diet ) for 2 sachet/day (total calorie 500 kcal

Experimental Dietary Supplement,Placebo Comparator Dietary Supplement

Neomune,Blendera

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Advance stage GI cancer who were scheduled to receive Palliative chemotherapy for first line treatment 2.Aged older than 20 years 3.Good Performance status (ECOG 0-2) 4.Prognosis more than 6 months 5.Able to eat via oral route route 6. PG-SGA score at least 4

Exclusion criteria

Exclusion criteria: 1.Contraindication to oral nutrition support or to high protein diet 2.Patients with organ dysfunctions (liver failure, kidney failure, Uncontrolled DM) 3. Patients who were also treated by radiation therapy 4. Patients refused to take any medical supplements used in this research. 5. Patients who receive G-CSF prior study

Design outcomes

Primary

Measure	Time frame
Rate of neutropenia grade II-IV before 2 weeks and 12 weeks after start chemotherapy CBC	—

Secondary

Measure	Time frame
percent of body weight change before 2 weeks,6 weeks and 12 weeks after start chemotherapy weighting scale,percent change of Pre-albumin, albumin, CRP, IL-6, CD3, CD4, CD8 before 2 weeks and 12 weeks after start chemotherapy central lab,percent change of PG-SGA score before 2 weeks,6 weeks and 12 weeks after start chemotherapy questionnaire interview,side effect from chemotherapy such as Mucositis, Febrile neutropenia, Diarrhea with in 12 weeks after start chemotherapy questionnaire interview,Percent change of Hand grip strength before 2 weeks,6 weeks and 12 weeks after start chemotherapy Hand grip dynamometer	—

Measure

Time frame

percent of body weight change before 2 weeks,6 weeks and 12 weeks after start chemotherapy weighting scale,percent change of Pre-albumin, albumin, CRP, IL-6, CD3, CD4, CD8 before 2 weeks and 12 weeks after start chemotherapy central lab,percent change of PG-SGA score before 2 weeks,6 weeks and 12 weeks after start chemotherapy questionnaire interview,side effect from chemotherapy such as Mucositis, Febrile neutropenia, Diarrhea with in 12 weeks after start chemotherapy questionnaire interview,Percent change of Hand grip strength before 2 weeks,6 weeks and 12 weeks after start chemotherapy Hand grip dynamometer

—

Countries

Thailand

Contacts

Public ContactRungprakai Injong

King Chulalongkorn Memorial Hospital

rungprakai_kwan@hotmail.com0805056151

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026