The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study

Study Overview
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Brief Summary
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We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.

Detailed Description
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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.

Official Title
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The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: Premium Amino Acids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group: chemotherapy<br>No intervention | |
| Experimental: experimental group: chemotherapy and nutrition support<br>Premium amino acids 1pc bid for 6 months | Dietary Supplement: Premium Amino Acids<br>* after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse event | Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times) | 2 weeks after chemotherapy | 
| 1)Nutrition assessment | albumin level between two group before every chemotherapy(total 12 times) | 2 weeks after chemotherapy | 
| 2)Nutrition assessment | pre-albumin level between two group before every chemotherapy(total 12 times) | 2 weeks after chemotherapy | 
| 1)Sarcopenia assessment muscle power | 1-1)Assessment with Grip strength(Kg) | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 
| 1)Sarcopenia assessment muscle power | 1-2)Assessment with Grip strength(Kg) | At 12th cycle of chemotherapy (each cycle is 2 weeks). | 
| 2)Sarcopenia assessment muscle power | 2-1)Assessment with ASM/heigh2(Kg/m2) | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 
| 2)Sarcopenia assessment muscle power | 2-2)Assessment with ASM/heigh2(Kg/m2) | At 12st cycle of chemotherapy (each cycle is 2 weeks). | 
| 3)Sarcopenia assessment | 3-1)Assessment with speed(m/s) | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 
| 3)Sarcopenia assessment | 3-2)Assessment with speed(m/s) | At 12th cycle of chemotherapy (each cycle is 2 weeks). | 
| 4)Sarcopenia assessment | 4-1)Assessment with DXA(g/cm2) | At 1st cycle of chemotherapy (each cycle is 2 weeks). | 
| 4)Sarcopenia assessment | 4-2)Assessment with DXA(g/cm2) | At 12th cycle of chemotherapy (each cycle is 2 weeks). | 
| 5)Sarcopenia assessment | 5-1)Assessment with abdominal CT | At 6th cycle of chemotherapy (each cycle is 2 weeks). | 
| 5)Sarcopenia assessment | 5-2)Assessment with abdominal CT | At 12th cycle of chemotherapy (each cycle is 2 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, Chemotherapy, Nutrition, Sarcopenia