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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Premium Amino Acids
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring colorectal cancer, Chemotherapy, Nutrition, Sarcopenia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital,KaohsiungRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group: chemotherapy

experimental group: chemotherapy and nutrition support

Arm Description

No intervention

Premium amino acids 1pc bid for 6 months

Outcomes

Primary Outcome Measures

Assessment of adverse event
Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times)
1)Nutrition assessment
albumin level between two group before every chemotherapy(total 12 times)
2)Nutrition assessment
pre-albumin level between two group before every chemotherapy(total 12 times)
1)Sarcopenia assessment muscle power
1-1)Assessment with Grip strength(Kg)
1)Sarcopenia assessment muscle power
1-2)Assessment with Grip strength(Kg)
2)Sarcopenia assessment muscle power
2-1)Assessment with ASM/heigh2(Kg/m2)
2)Sarcopenia assessment muscle power
2-2)Assessment with ASM/heigh2(Kg/m2)
3)Sarcopenia assessment
3-1)Assessment with speed(m/s)
3)Sarcopenia assessment
3-2)Assessment with speed(m/s)
4)Sarcopenia assessment
4-1)Assessment with DXA(g/cm2)
4)Sarcopenia assessment
4-2)Assessment with DXA(g/cm2)
5)Sarcopenia assessment
5-1)Assessment with abdominal CT
5)Sarcopenia assessment
5-2)Assessment with abdominal CT

Secondary Outcome Measures

Full Information

First Posted
August 26, 2020
Last Updated
January 26, 2021
Sponsor
Chang Gung Memorial Hospital
Collaborators
Hanben Enterprise
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1. Study Identification

Unique Protocol Identification Number
NCT04567459
Brief Title
The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
Official Title
The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2021 (Anticipated)
Primary Completion Date
February 22, 2021 (Anticipated)
Study Completion Date
February 22, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Hanben Enterprise

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, Chemotherapy, Nutrition, Sarcopenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group: chemotherapy
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
experimental group: chemotherapy and nutrition support
Arm Type
Experimental
Arm Description
Premium amino acids 1pc bid for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Premium Amino Acids
Intervention Description
after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening
Primary Outcome Measure Information:
Title
Assessment of adverse event
Description
Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times)
Time Frame
2 weeks after chemotherapy
Title
1)Nutrition assessment
Description
albumin level between two group before every chemotherapy(total 12 times)
Time Frame
2 weeks after chemotherapy
Title
2)Nutrition assessment
Description
pre-albumin level between two group before every chemotherapy(total 12 times)
Time Frame
2 weeks after chemotherapy
Title
1)Sarcopenia assessment muscle power
Description
1-1)Assessment with Grip strength(Kg)
Time Frame
At 1st cycle of chemotherapy (each cycle is 2 weeks).
Title
1)Sarcopenia assessment muscle power
Description
1-2)Assessment with Grip strength(Kg)
Time Frame
At 12th cycle of chemotherapy (each cycle is 2 weeks).
Title
2)Sarcopenia assessment muscle power
Description
2-1)Assessment with ASM/heigh2(Kg/m2)
Time Frame
At 1st cycle of chemotherapy (each cycle is 2 weeks).
Title
2)Sarcopenia assessment muscle power
Description
2-2)Assessment with ASM/heigh2(Kg/m2)
Time Frame
At 12st cycle of chemotherapy (each cycle is 2 weeks).
Title
3)Sarcopenia assessment
Description
3-1)Assessment with speed(m/s)
Time Frame
At 1st cycle of chemotherapy (each cycle is 2 weeks).
Title
3)Sarcopenia assessment
Description
3-2)Assessment with speed(m/s)
Time Frame
At 12th cycle of chemotherapy (each cycle is 2 weeks).
Title
4)Sarcopenia assessment
Description
4-1)Assessment with DXA(g/cm2)
Time Frame
At 1st cycle of chemotherapy (each cycle is 2 weeks).
Title
4)Sarcopenia assessment
Description
4-2)Assessment with DXA(g/cm2)
Time Frame
At 12th cycle of chemotherapy (each cycle is 2 weeks).
Title
5)Sarcopenia assessment
Description
5-1)Assessment with abdominal CT
Time Frame
At 6th cycle of chemotherapy (each cycle is 2 weeks).
Title
5)Sarcopenia assessment
Description
5-2)Assessment with abdominal CT
Time Frame
At 12th cycle of chemotherapy (each cycle is 2 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Hsiang Hu, M.D.
Phone
886-975056227
Email
gary.hu0805@gmail.com
Facility Information:
Facility Name
Chang Gung Memorial Hospital,Kaohsiung
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Hsiang Hu
Phone
+886-7-7317123
Ext
8008
Email
gary.hu0805@gmail.com

12. IPD Sharing Statement

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

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