Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks |
The questionnaire will finished to record the side effects, including nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy, skin rashes, and hand-food syndrome before and after the treatment. |
24 weeks |
|
Secondary |
Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks |
The FACT-G questionnaire will record the quality of life by subjects at 12-weeks and-24 weeks. There are 4 domains of quality of life will be measured, including physical well-being, social/family well-being, emotional well-being, functional well-being. All domains will sum as total score of 108, and each domain will also evaluated. |
24 weeks |
|
Secondary |
Variability in BMI (Body Mass Index) |
BMI will calculated with weight and height combined in kg/m^2. Measured every visit (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks |
Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks. |
12 weeks |
|
Secondary |
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks |
Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks. |
24 weeks |
|
Secondary |
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks |
Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks. |
12 weeks |
|
Secondary |
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks |
Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks. |
24 weeks |
|
Secondary |
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks |
Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks. |
12 weeks |
|
Secondary |
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks |
Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks. |
24 weeks |
|
Secondary |
Change from baseline in levels of TNF-a (Tumor Necrosis Factor-a) in pg/mL at 12 weeks |
Blood samples will collected to examine the variation of TNF-a from baseline at 12 weeks. |
12 weeks |
|
Secondary |
Change from baseline in levels of TNF-a (Tumor Necrosis Factor-a) in pg/mL at 24 weeks |
Blood samples will collected to examine the variation of TNF-a from baseline at 24 weeks. |
24 weeks |
|
Secondary |
Change from baseline in gut microbiome at 12 weeks |
Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 12 weeks by NGS (Next Generation Sequencing) analysis. |
12 weeks |
|
Secondary |
Change from baseline in gut microbiome at 24 weeks |
Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 24 weeks by NGS (Next Generation Sequencing) analysis. |
24 weeks |
|
Secondary |
Variability in levels of ALT (Alanine Aminotransferase) in IU/L |
ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of AST (Aspartate Aminotransferase) in IU/L |
AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of Creatinine in mg/dL |
Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of Hb (Hemoglobin) in g/dL |
Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of RBC (Red Blood Cell count) in 10^6/µL |
RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of Ht (Hematocrite) in % |
Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of WBC(White Blood Cell count) in 10^3/µL |
WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of MCV (Mean Corpuscular Volume) in fL |
MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg |
MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL |
MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|
Secondary |
Variability in levels of ANC (Absolute Neutrophil Count) in mm^3 |
Total neutrophils and WBC collected from routine medical records at each visit to calculate ANC levels. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) ANC is calculated as 10 x WBC count in 1000s x (%Segment neutrophils + % bands neutrophils). |
24 weeks |
|
Secondary |
Variability in levels of platelet in 10^3/µL |
Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) |
24 weeks |
|