Status:
UNKNOWN
Doctor-Recommended Home-Based Exercise Program or Relaxation Training in Improving Physical Function and Controlling Symptoms in Patients With Stage IV or Recurrent Colon Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this study is to compare the effects of exercise with the effects of relaxation training on physical function (how well participants perform normal daily activities) and symptoms related t...
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If you are in the exercise group, you will receiv...
Eligibility Criteria
Inclusion
- Diagnosis of stage IV or recurrent colorectal cancer
- Age \>/= 18 years
- ECOG performance status of 0 -1
- Able to communicate in English or Spanish
- Able to give informed consent
- Adequate organ function -Total bilirubin \< 1.5 x the institutional upper-normal limits (IUNL); AST (SGOT) and/or ALT (SGPT) \< 2.5 x IUNL; Patients with liver metastasis AST/ (SGOT) and/or ALT (SGPT) \< 5 x IUNL
- Adequate bone marrow function: - Absolute neutrophil count \> 1,000/microLiters; Platelets \> 50,000/microLiters
- Able to ambulate without assistance
- Has access to a telephone in order to receive pre-recorded telephone messages and for multiple counseling sessions.
Exclusion
- Major surgery in the past 8 weeks
- Medical contraindications to home-based exercise as defined by the treating physician
- Symptomatic Bone Metastases
- Unstable Angina (current symptomatic angina at time of enrollment)
- Class III/IV heart failure according to NYHA classification system
- Pulmonary conditions that require oxygen
- Unable to ambulate without assistance (cane, walker, etc)
- Exercising at a moderate-vigorous intensity for 150 minutes or more per week, exercising at a vigorous intensity for more than 20 minutes on 3 or more days per week, or performing resistance exercises for more than 20 minutes per day on two or more days per week for 3 months or more.
Key Trial Info
Start Date :
November 5 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00985400
Start Date
November 5 2010
End Date
March 31 2023
Last Update
March 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009