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Clinical Trials/NCT04567459
NCT04567459
Unknown
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country100 target enrollmentJanuary 27, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Chang Gung Memorial Hospital
Enrollment
100
Locations
1
Primary Endpoint
Assessment of adverse event
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2021
End Date
February 22, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Wan-Hsiang Hu

Attending physician

Chang Gung Memorial Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Assessment of adverse event

Time Frame: 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

Time Frame: 2 weeks after chemotherapy

pre-albumin level between two group before every chemotherapy(total 12 times)

1)Sarcopenia assessment muscle power

Time Frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).

1-2)Assessment with Grip strength(Kg)

3)Sarcopenia assessment

Time Frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).

3-2)Assessment with speed(m/s)

1)Nutrition assessment

Time Frame: 2 weeks after chemotherapy

albumin level between two group before every chemotherapy(total 12 times)

2)Sarcopenia assessment muscle power

Time Frame: At 12st cycle of chemotherapy (each cycle is 2 weeks).

2-2)Assessment with ASM/heigh2(Kg/m2)

5)Sarcopenia assessment

Time Frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).

5-2)Assessment with abdominal CT

4)Sarcopenia assessment

Time Frame: At 12th cycle of chemotherapy (each cycle is 2 weeks).

4-2)Assessment with DXA(g/cm2)

Study Sites (1)

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