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

Not Applicable

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Premium Amino Acids

• Registration Number: NCT04567459
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-09-23
• Study First Posted: 2020-09-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Study Start: 2021-01-27
• Last Update Posted: 2021-01-28
• Primary Completion: 2021-02-22
• Study Completion: 2021-02-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group: chemotherapy and nutrition support	Premium Amino Acids	Premium amino acids 1pc bid for 6 months

Primary Outcome Measures

Name	Time	Method
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)
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 12th cycle of chemotherapy (each cycle is 2 weeks).	1-2)Assessment with Grip strength(Kg)
3)Sarcopenia assessment	At 12th cycle of chemotherapy (each cycle is 2 weeks).	3-2)Assessment with speed(m/s)
1)Nutrition assessment	2 weeks after chemotherapy	albumin level between two group before every chemotherapy(total 12 times)
2)Sarcopenia assessment muscle power	At 12st cycle of chemotherapy (each cycle is 2 weeks).	2-2)Assessment with ASM/heigh2(Kg/m2)
5)Sarcopenia assessment	At 12th cycle of chemotherapy (each cycle is 2 weeks).	5-2)Assessment with abdominal CT
4)Sarcopenia assessment	At 12th cycle of chemotherapy (each cycle is 2 weeks).	4-2)Assessment with DXA(g/cm2)

Trial Locations

Locations (1)

Chang Gung Memorial Hospital,Kaohsiung; 🇨🇳 Kaohsiung, Taiwan