Developing Objective Fatigue Indicators in Colorectal Cancer Survivors.

Colorectal Cancer Clinical Trial

Official title:

Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01700283
• Other study ID #: 201208026RIC
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2012
• Last updated: November 12, 2012
• Start date: October 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2012
• Source: National Taiwan University Hospital
• Contact: Shiow-Ching Shun, PHD
• Phone: 886-2-23123456
• Email: scshun[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Interventional

Clinical Trial Summary

The aims of this four-year study are to

1. Explore exercise behavior, exercise barriers, and identify the significant factors for exercise behavior in colorectal cancer survivors.

2. Explore the relationships among fatigue, muscle strength, and metabolomics and further examine the possible biomarkers from muscle strength and metabolomics for fatigue.

3. Develop a clinical guidelines of home-based fatigue management and exercise program and test its effect on decreasing fatigue for patients with colorectal cancer after surgery in Taiwan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 306
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Colorectal cancer survivors completed treatment at least 3 months in clinics.

• Aged above 20.

Exclusion Criteria:

• KPS < 60

• Stage 4

• Bone meta

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• exercise education and walking program
12-week moderate intensity walking program

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Developing Objective Fatigue Indicators: Exploring the Relationships Among Fatigue, Muscle Power and Metabolomics Through Fatigue Management and Individualized Exercise Education Program in Colorectal Cancer Survivors	Develope the clinical exercise education program guideline for patients with early stage colorectal cancer survivor.	four-year study	No