Stage IV Colorectal CancerNCT03111823
Exercise Program During Chemotherapy in Metastatic Colorectal Cancer
A study testing Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Stage IV Colorectal Cancer, run by University of Southern California at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Colorectal Cancer
- What is being tested?
- Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2016to 5 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles County-USC Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Conditions
- Stage IV Colorectal Cancer
- Being tested
- Exercise Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Undergo aerobic exercise sessions
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (aerobic exercise) | Experimental | 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. Receives: Behavioral: Exercise Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline up to 31 weeks
Change in cancer-related fatigue
Assessed by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Scale
Measured: Baseline up to 31 weeks
Change in QOL
Assessed by the Functional Assessment of Cancer Therapy-Colorectal cancer (FACT-C)
Measured: Baseline up to 31 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start7 Jul 2016
- Primary completion5 Jul 2018
- Study completion5 Jul 2018
Why it stopped: Insufficient Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christina Dieli-Conwright, Ph.D., Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111823
- Sponsor's protocol ID
- 3C-16-1
- Other IDs
- NCI-2016-01089, 3C-16-1, P30CA014089
- Status last verified
- Aug 2018
- First submitted
- 29 Jul 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a 6-Week Aerobic Exercise Program During Chemotherapy for Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03111823
- Acronym / sponsor ID
- 3C-16-1
- Conditions
- Stage IV Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient Accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jul 2016 (actual)
- Primary completion
- 5 Jul 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (aerobic exercise) | Experimental | Behavioral: Exercise Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionUndergo aerobic exercise sessions | Behavioural | Supportive Care (aerobic exercise) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (aerobic exercise) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (aerobic exercise) |
Primary outcome
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.
3 secondary outcomes
Change in biomarkers of systemic inflammation
Time frame: Baseline up to 31 weeks
Change in cancer-related fatigue
Time frame: Baseline up to 31 weeks
Change in QOL
Time frame: Baseline up to 31 weeks
Results and safety
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Dieli-Conwright, Ph.D. principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Quality-of-Life Assessment and Questionnaire Administration in people with Stage IV Colorectal Cancer, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of minutes exercised per week with >80% total weekly minutes (48/60 minutes) completed (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.