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Trial record 36 of 575 for:    colon cancer | ( Map: California, United States )

Exercise Program During Chemotherapy in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03111823
Recruitment Status : Terminated (Insufficient Accrual)
First Posted : April 13, 2017
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Stage IV Colorectal Cancer Behavioral: Exercise Intervention Other: Quality-of-Life Assessment Other: Questionnaire Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
Actual Study Start Date : July 7, 2016
Actual Primary Completion Date : July 5, 2018
Actual Study Completion Date : July 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supportive Care (aerobic exercise)
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.
Behavioral: Exercise Intervention
Undergo aerobic exercise sessions

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed [ Time Frame: Up to 6 weeks ]
    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 :
  1. Change in biomarkers of systemic inflammation [ Time Frame: Baseline up to 31 weeks ]
    Change in biomarkers will be examined by a paired sample t-test, with a level of significance set at p <0.05.

  2. Change in cancer-related fatigue [ Time Frame: Baseline up to 31 weeks ]
    Assessed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale

  3. Change in QOL [ Time Frame: Baseline up to 31 weeks ]
    Assessed by the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C)


Other Outcome Measures:
  1. Change in arterial stiffness/geometry [ Time Frame: Baseline up to 31 weeks ]
    Assessed by ultrasound

  2. Change in endothelial function [ Time Frame: Baseline up to 31 weeks ]
    Assessed by flow-mediated dilation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03111823


Locations
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United States, California
Los Angeles County-USC Medical Center
Los Angeles, California, United States, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Christina Dieli-Conwright, Ph.D. University of Southern California

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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03111823     History of Changes
Other Study ID Numbers: 3C-16-1
NCI-2016-01089 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
3C-16-1 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases