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Exercise Program During Chemotherapy in Metastatic Colorectal Cancer

Primary Purpose

Stage IV Colorectal Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage IV Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Newly diagnosed metastatic (stage IV) colorectal cancer
  • Undergoing chemotherapy (have had 1 or 2 chemotherapy cycles infused at time of data collection; this will allow for any systemic inflammatory changes due to chemotherapy to set in); only patients with 1st or 2nd line therapy will be included
  • Able to initiate a supervised exercise program (free from any CV, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
  • Free from uncontrolled chronic disease including diabetes, hypertension, or thyroid disease
  • Currently participate in less than 60 minutes of physical activity/week
  • Willing to travel to the exercise facility at University of Southern California (USC) (parking fees and public transportation permits will be provided)
  • Speak English or Spanish

Exclusion Criteria:

  • Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc)
  • Moderate to highly active level of physical activity (e.g. currently participating in > 60 minutes of moderate aerobic activity weekly)
  • Orthopedic or other restrictions or contraindications to exercise
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants

Sites / Locations

  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (aerobic exercise)

Arm Description

Patients undergo aerobic exercise sessions consisting of cycling or walking at a low-moderate intensity and progressing to moderate intensity for 30 minutes 2 times a week for up to 8 weeks.

Outcomes

Primary Outcome Measures

Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed
The study will assess the feasibility using average weekly minutes of exercise completion (minutes/week) of all participants. Feasibility will be determined based on the total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed deeming this trial as feasible.

Secondary Outcome Measures

Change in biomarkers of systemic inflammation
Change in biomarkers will be examined by a paired sample t-test, with a level of significance set at p <0.05.
Change in cancer-related fatigue
Assessed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Change in QOL
Assessed by the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C)

Full Information

First Posted
July 29, 2016
Last Updated
August 9, 2018
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03111823
Brief Title
Exercise Program During Chemotherapy in Metastatic Colorectal Cancer
Official Title
Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
July 7, 2016 (Actual)
Primary Completion Date
July 5, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot clinical trial studies how well aerobic exercise works in improving quality of life and health-related outcomes in patients with stage IV colorectal cancer undergoing chemotherapy. Aerobic exercise during chemotherapy may improve quality of life and reduce fatigue and inflammation in the blood related to heart disease and diabetes in patients with stage IV colorectal cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether a 6-week indoor or outdoor aerobic exercise program is feasible in patients with metastatic colorectal cancer (mCRC) undergoing chemotherapy and to explore patient's preferences for indoor versus (vs.) outdoor exercise. II. To determine the effects of a 6-week indoor or outdoor aerobic exercise program on cancer-related fatigue and quality of life (QOL) in patients with mCRC. SECONDARY OBJECTIVES: I. To determine the effects of a 6-week indoor or outdoor aerobic exercise program on body composition (lean body mass, fat mass, body fat percentage [%]) and biomarkers of systemic inflammation (interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-a], C-reactive protein [CRP]) in patients with mCRC. TERTIARY OBJECTIVES: I. To determine the effects of a 6-week exercise program on cardiovascular (CV) function. OUTLINE: Patients undergo aerobic exercise sessions consisting of cycling or walking at a low-moderate intensity and progressing to moderate intensity for 30 minutes 2 times a week for up to 8 weeks. After completion of study treatment, patients are followed up for 6 weeks and at weeks 13, 19, and 31.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Colorectal Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (aerobic exercise)
Arm Type
Experimental
Arm Description
Patients undergo aerobic exercise sessions consisting of cycling or walking at a low-moderate intensity and progressing to moderate intensity for 30 minutes 2 times a week for up to 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo aerobic exercise sessions
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed
Description
The study will assess the feasibility using average weekly minutes of exercise completion (minutes/week) of all participants. Feasibility will be determined based on the total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed deeming this trial as feasible.
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Change in biomarkers of systemic inflammation
Description
Change in biomarkers will be examined by a paired sample t-test, with a level of significance set at p <0.05.
Time Frame
Baseline up to 31 weeks
Title
Change in cancer-related fatigue
Description
Assessed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Time Frame
Baseline up to 31 weeks
Title
Change in QOL
Description
Assessed by the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C)
Time Frame
Baseline up to 31 weeks
Other Pre-specified Outcome Measures:
Title
Change in arterial stiffness/geometry
Description
Assessed by ultrasound
Time Frame
Baseline up to 31 weeks
Title
Change in endothelial function
Description
Assessed by flow-mediated dilation
Time Frame
Baseline up to 31 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed metastatic (stage IV) colorectal cancer Undergoing chemotherapy (have had 1 or 2 chemotherapy cycles infused at time of data collection; this will allow for any systemic inflammatory changes due to chemotherapy to set in); only patients with 1st or 2nd line therapy will be included Able to initiate a supervised exercise program (free from any CV, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity) Free from uncontrolled chronic disease including diabetes, hypertension, or thyroid disease Currently participate in less than 60 minutes of physical activity/week Willing to travel to the exercise facility at University of Southern California (USC) (parking fees and public transportation permits will be provided) Speak English or Spanish Exclusion Criteria: Uncontrolled hypertension or other uncontrolled chronic disease (e.g. diabetes mellitus, thyroid disease, pulmonary disease, etc) Moderate to highly active level of physical activity (e.g. currently participating in > 60 minutes of moderate aerobic activity weekly) Orthopedic or other restrictions or contraindications to exercise Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Dieli-Conwright, Ph.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Exercise Program During Chemotherapy in Metastatic Colorectal Cancer

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