ClinicalTrials.Veeva

Menu

Microbiome, Exercise Tracking Study: Among Individuals at High Risk for Colorectal Cancer (METS)

Columbia University logo

Columbia University

Status

Completed

Conditions

Colorectal Cancer

Treatments

Behavioral: Physical activity intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT02780284
AAAP1611

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

21 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Fluent in English or Spanish;
  2. At high risk of developing colorectal cancer;
  3. No history of colorectal cancer, including germ-line heritable colorectal cancers such as Familial Adenomatous Polyposis (FAP) and Hereditary Nonpolyposis Colorectal Cancer (HNPCC);
  4. No use of antibiotics in the previous 3 months; or current regular use of antibiotics
  5. Access to either smart phone or computer; and
  6. Currently physically inactive.

Exclusion criteria

Any criterion not met under inclusion.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Physical activity intervention
Experimental group
Description:
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.
Treatment:
Behavioral: Physical activity intervention

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems