Stage II Colon CancerNCT02250053
Exercise and Colon Cancer
A study testing Exercise in people with Stage II Colon Cancer and Stage III Colon Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II Colon Cancer, Stage III Colon Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 15 Jan 2016
- 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
- histologically confirmed TNM stage II-III CC;
- completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
- ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
- age ≥18 years;
- written physician approval;
- no additional surgery planned within the 6-month intervention (including colostomy reversal);
- ability to walk unaided for 6-minutes;
- no contraindications to exercise using the PA readiness questionnaire (PAR-Q), unless physician approves participation with specific knowledge of this contraindication.
Who cannot join
- history of another primary invasive cancer (other than non-melanoma skin-cancer);
- evidence of metastatic CC (i.e., TNM M1);
- planning to receive any additional adjuvant chemotherapy;
- pregnant or breast feeding;
- unable to provide baseline blood sample;
- cardiac conditions, including the following:
Show all 13Show fewer
- myocardial infarction or coronary revascularization procedure within prior 3 months;
- uncontrolled hypertension (systolic ≥180 mmHg or diastolic ≥100 mmHg);
- high-risk or uncontrolled arrhythmias;
- clinically significant valvular disease;
- decompensated heart failure;
- known aortic aneurysm;
- any other condition that may impede testing of the study hypothesis or make it unsafe to engage in the exercise program (determined by the investigative team).
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study
Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.
- Conditions
- Stage II Colon Cancer, Stage III Colon Cancer
- Being tested
- Exercise
- Keywords
- stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | aerobic exercise on soluble intercellular adhesion molecules Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
Measured: 2 years
Secondary outcomes (4)
Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;
Measured: 6 months
Visceral adipose tissue and anthropometric measures at baseline and six-months;
Measured: 6 months
Fasting insulin measured at baseline and six-months;
Measured: six months
Circulating tumor cells measured at baseline and six-months.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startDec 2015
- Primary completionJan 2016
- Study completion15 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage II Colon CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- exercise
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn Schmitz, PhD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250053
- Sponsor's protocol ID
- UPCC 10214
- Status last verified
- Apr 2020
- First submitted
- 22 Sep 2014
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown JC, Compton SLE, Meyerhardt JA, Spielmann G, Yang S. The dose-response effect of aerobic exercise on inflammation in colon cancer survivors. Front Oncol. 2023 Dec 12;13:1257767. doi: 10.3389/fonc.2023.1257767. eCollection 2023.
PubMed 38148846
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COURAGE Trial: Colon Recurrence and Aerobic Exercise: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02250053
- Acronym / sponsor ID
- UPCC 10214
- Conditions
- Stage II Colon Cancer, Stage III Colon Cancer
- Keywords
- stage II and stage III colon cancer survivors, who have completed curative treatment i.e., surgical resection and chemotherapy for their colon cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- 15 Jan 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- 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.
Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
- Model description
- exercise
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Other: Exerciseaerobic exercise on soluble intercellular adhesion molecules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologically confirmed TNM stage II-III CC;
- completed surgical resection and adjuvant chemotherapy (if applicable) within 1-24 months before entering the study;
- ≤120 min/wk of self-reported moderate or vigorous intensity physical activity using the Paffenbarger physical activity questionnaire;
- age ≥18 years;
- written physician approval;
Key exclusion criteria (13 listed)
- history of another primary invasive cancer (other than non-melanoma skin-cancer);
- evidence of metastatic CC (i.e., TNM M1);
- planning to receive any additional adjuvant chemotherapy;
- pregnant or breast feeding;
- unable to provide baseline blood sample;
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 | Other | exercise |
Primary outcome
1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers.
Time frame: 2 years
4 secondary outcomes
Exercise adherence, quantified as the percentage of total dose completed relative to the total dose prescribed during the six-month study;
Time frame: 6 months
Visceral adipose tissue and anthropometric measures at baseline and six-months;
Time frame: 6 months
Fasting insulin measured at baseline and six-months;
Time frame: six months
Circulating tumor cells measured at baseline and six-months.
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 38148846Brown JC, Compton SLE, Meyerhardt JA, Spielmann G, Yang S. The dose-response effect of aerobic exercise on inflammation in colon cancer survivors. Front Oncol. 2023 Dec 12;13:1257767. doi: 10.3389/fonc.2023.1257767. eCollection 2023.
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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.
Kathryn Schmitz, PhD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Stage II Colon Cancer and Stage III Colon Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site 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 8 inclusion and 13 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: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1. The biological efficacy of aerobic exercise on soluble intercellular adhesion molecule-1 (sICAM-1), and soluble vascular adhesion molecule-1 (sVCAM-1) prognostic biomarkers. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02250053, which also lists 1 linked publication.
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 9 Apr 2020.