Exercise Program During Chemotherapy in Metastatic Colorectal Cancer

Stage IV Colorectal Cancer Clinical Trial

Official title:

Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03111823
• Other study ID #: 3C-16-1
• Secondary ID: NCI-2016-010893C
• Status: Terminated
• Phase: N/A
• Start date: July 7, 2016
• Est. completion date: July 5, 2018

Study information

• Verified date: August 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 5, 2018
• Est. primary completion date: July 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Stage IV Colorectal Cancer

Intervention

Behavioral:
• Exercise Intervention
Undergo aerobic exercise sessions

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Los Angeles County-USC Medical Center	Los Angeles	California
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in arterial stiffness/geometry	Assessed by ultrasound	Baseline up to 31 weeks
Other	Change in endothelial function	Assessed by flow-mediated dilation	Baseline up to 31 weeks
Primary	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.	Up to 6 weeks
Secondary	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.	Baseline up to 31 weeks
Secondary	Change in cancer-related fatigue	Assessed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale	Baseline up to 31 weeks
Secondary	Change in QOL	Assessed by the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C)	Baseline up to 31 weeks