Treatment for Cancer of Colon

Phase-Based Estimates
1
Effectiveness
1
Safety
Upittsburgh, Pittsburgh, PA
Cancer of Colon+1 More
Eligibility
18+
All Sexes
Eligible conditions
Cancer of Colon

Study Summary

This study is evaluating whether a fiber supplement may help reduce colon cancer risk in Alaska natives.

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Eligible Conditions

  • Cancer of Colon
  • Colonic Neoplasms
  • Malignant Neoplasm of Colon

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 2 secondary outcomes in patients with Cancer of Colon. Measurement will happen over the course of 4 weeks.

4 weeks
colonic microbiota
colonic mucosal proliferation
colonic secondary bile acids

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Resistant Starch
Placebo group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Resistant Starch
DietarySupplement
70g high-amylose maize starch which contains 42g of type 2 resistant starch
Digestible Starch
DietarySupplement
70g of fully digestible starch comprised of amylopectin corn starch.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 weeks for reporting.

Who is running the study

Principal Investigator
S. O.
Stephen O'Keefe, MD
University of Pittsburgh

Closest Location

Upittsburgh - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Inclusion Criteria: Healthy AN volunteers (from GI standpoint) between 40-70 years (age at which colon cancer screening colonoscopy is recommended in this population) and BMI between 18-40 Kg/m2. It should be noted that in our previous study, we found no difference in the responses of the key parameters (mucosal biomarkers, butyrate and secondary bile acid producers, fecal SCFA and bile acids) to increased fiber diets between those with normal body weight, those overweight, and those who were obese (Nature Comm Supplement). Patients who have, or have had noncancerous polyps removed previously by colonoscopy will be eligible. Alaska Native race will be defined as those eligible to receive health care through the Alaska Tribal Health System.

Patient Q&A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Cancer of Colon by sharing your contact details with the study coordinator.