Colorectal Cancer
Conditions
Keywords
colorectal cancer, Chemotherapy, Nutrition, Sarcopenia
Brief summary
We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.
Detailed description
Colorectal cancer is the most common cancer in Taiwan. Side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. Sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. The studies of intervention include nutrition consultant and treatment like protein, fish oil or Vitamin D supplement. Premium amino acids include multiple amino acids and organic Selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.
Interventions
DIETARY_SUPPLEMENTPremium Amino Acids
after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening
Sponsors
Hanben Enterprise
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 20 * Radical operation for stage III and stage II with high risk colorectal cancer * Agree to join the trial and sign the informed consent form
Exclusion criteria
* Unable to receive chemotherapy * Unstable vital sign * Not suitable after evaluation by Principal Investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse event | 2 weeks after chemotherapy | Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times) |
| 1)Nutrition assessment | 2 weeks after chemotherapy | albumin level between two group before every chemotherapy(total 12 times) |
| 2)Nutrition assessment | 2 weeks after chemotherapy | pre-albumin level between two group before every chemotherapy(total 12 times) |
| 1)Sarcopenia assessment muscle power | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 1-1)Assessment with Grip strength(Kg) |
| 2)Sarcopenia assessment muscle power | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 2-1)Assessment with ASM/heigh2(Kg/m2) |
| 3)Sarcopenia assessment | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 3-1)Assessment with speed(m/s) |
| 4)Sarcopenia assessment | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 4-1)Assessment with DXA(g/cm2) |
| 5)Sarcopenia assessment | At 6th cycle of chemotherapy (each cycle is 2 weeks). | 5-1)Assessment with abdominal CT |
Countries
Taiwan
Contacts
Primary ContactWan-Hsiang Hu, M.D.
Outcome results
None listed