Colorectal CancerMETSNCT02780284
Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer
A study testing Physical activity intervention in people with Colorectal Cancer, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this study has 2 aims: Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 15 Sep 2020
- 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 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English or Spanish;
- At high risk of developing colorectal cancer;
- No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
- No use of antibiotics in the previous 3 months; or current regular use of antibiotics
- Access to either smart phone or computer; and
- Currently physically inactive.
Who cannot join
- Any criterion not met under inclusion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer
The purpose of this study has 2 aims:
Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Investigators hypothesize that it will be possible to recruit and retain this patient population to a physical activity intervention trial.
Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing the gut microbiome data. Investigators hypothesize that all of these steps are feasible.
Read the detailed description
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and is the third most common cancer in men and women. CRC risk factors include genetic predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical activity, obesity). There are very limited data on the differences in the gut microbiota among populations at different levels of CRC risk, as well as the effects of behavioral interventions to alter the gut microbiome.
- Conditions
- Colorectal Cancer
- Being tested
- Physical activity intervention
- Keywords
- Gut Microbiota, Butyrate, Physical activity
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
150 minutes per week of moderate intensity cardiovascular exercise. The exercise sessions will include a minimum of 30 minutes of exercise each day, 3 to 5 times per week for a total of 150 minutes of exercise per week.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | Subjects at higher risk of developing colorectal cancer will maintain the current level of activity during the first 4 weeks and exercise 150 minutes per week during the last 4 weeks. During the entire study, subjects will wear a Fitbit device on their wrist. Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants retained at the end of study
To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial
Measured: 8 weeks
Secondary outcomes (1)
Percentage of participants with collected, processed, and analyzed stool samples
To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing gut microbiome data
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startMar 2015
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Greenlee, ND, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780284
- Sponsor's protocol ID
- AAAP1611
- Acronym
- METS
- Status last verified
- Oct 2022
- First submitted
- 19 May 2016
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota, Butyrate, Inflammation and Physical Activity: A Pilot Study Among Individuals at High Risk for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02780284
- Acronym / sponsor ID
- METS / AAAP1611
- Conditions
- Colorectal Cancer
- Keywords
- Gut Microbiota, Butyrate, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 23 May 2016 (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.
The purpose of this study has 2 aims:
Aim 1: To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial. Investigators hypothesize that it will be possible to recruit and retain this patient population to a physical activity intervention trial.
Aim 2: To demonstrate the feasibility of collecting, processing, storing stool samples and analyzing the gut microbiome data. Investigators hypothesize that all of these steps are feasible.
Detailed description
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the U.S. and is the third most common cancer in men and women. CRC risk factors include genetic predisposition, host factors and modifiable lifestyle behaviors (e.g., diet, physical activity, obesity). There are very limited data on the differences in the gut microbiota among populations at different levels of CRC risk, as well as the effects of behavioral interventions to alter the gut microbiome.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionSubjects at higher risk of developing colorectal cancer will maintain the current level of activity during the first 4 weeks and exercise 150 minutes per week during the last 4 weeks. During the entire study, subjects will wear a Fitbit device on their wrist. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fluent in English or Spanish;
- At high risk of developing colorectal cancer;
- No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
- No use of antibiotics in the previous 3 months; or current regular use of antibiotics
- Access to either smart phone or computer; and
Key exclusion criteria (1 listed)
- Any criterion not met under inclusion.
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 |
|---|---|---|
| Physical activity intervention150 minutes per week of moderate intensity cardiovascular exercise. The exercise sessions will include a minimum of 30 minutes of exercise each day, 3 to 5 times per week for a total of 150 minutes of exercise per week. | Behavioural | Physical activity intervention |
Primary outcome
Percentage of participants retained at the end of study
Time frame: 8 weeks
To demonstrate the feasibility of recruiting and retaining adults at high risk of colorectal cancer to a physical activity intervention trial
1 secondary outcome
Percentage of participants with collected, processed, and analyzed stool samples
Time frame: 8 weeks
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 13 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Heather Greenlee, ND, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Colorectal Cancer, run by Columbia University 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 6 inclusion and 1 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 13 Oct 2022. 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?
Percentage of participants retained at the end of study (time frame: 8 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 Oct 2022.