The Effect of Immunonutrition and Chemotherapy Induced Neutropenia in Advanced Gastrointestinal Cancer Receiving Palliative Chemotherapy A Pilot Randomized Controlled Trial
Phase 3
- Conditions
- Malnutrition in Advanced Gastrointestinal Cancer Receiving Palliative Chemotherapyadvance gastrointestinal cancer, malnutrition
- Registration Number
- TCTR20210723001
- Lead Sponsor
- Chulalongkorn university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of neutropenia grade II-IV before 2 weeks and 12 weeks after start chemotherapy CBC
- Secondary Outcome Measures
Name Time Method 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