Study on Linaclotide for Treating Stages 0-3 Colorectal Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
ClinicalTrials ID:NCT03796884
This clinical trial is exploring how well the drug linaclotide works in treating patients with early to mid-stage colorectal cancer. Linaclotide is a small protein that helps intestinal cells release water and salt.
Patient Parameters
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Program Overview
The purpose of this study is to see if linaclotide, taken as a daily pill for 7 days, can affect certain biological markers in patients with early to mid-stage colorectal cancer. Researchers will compare these effects to those seen with a placebo. The study also aims to confirm the safety of linaclotide in patients with colorectal adenomas or cancer.
Description
In this study, participants are divided into two groups. One group will take linaclotide daily for 7 days, while the other group will take a placebo. Both groups will undergo a standard colonoscopy or surgery on the last day of treatment. The main goal is to see if linaclotide affects specific biological markers in the body. Researchers will also look at the safety and tolerability of the drug. After the treatment, participants will have a follow-up visit on day 14 to check their health and any effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Have a history of one or more colorectal adenomas or have stage 0-3 colorectal cancer and are scheduled for surgery.
- Able to understand and sign a consent form and follow study procedures.
- Can swallow capsules without difficulty.
- Can keep a diary of pill intake.
- Willing to use effective birth control during the study if of childbearing potential.
- No severe health issues that could interfere with the study, as determined by a doctor.
Exclusion Criteria
- History of slow stomach emptying (gastroparesis).
- History of celiac disease.
- Have inflammatory bowel diseases like Crohn's or ulcerative colitis.
- Have microscopic colitis.
- Have taken linaclotide in the last 30 days.
- Have any cancer other than colorectal cancer or have had recent cancer treatments.
- Are participating in another clinical trial or have recently participated in one.
- Have allergies to similar drugs as linaclotide.
- Have uncontrolled illnesses or conditions that could interfere with the study.
- Are pregnant or breastfeeding.
- Have bleeding or blood clotting issues.
- Are at risk for gastrointestinal blockages.
- Use blood thinners that cannot be safely stopped before the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| Sidney Kimmel Cancer Center at Thomas Jefferson University | 19126 | Philadelphia | Pennsylvania |
| VA Puget Sound Health Care Sysem | 98108 | Seattle | Washington |
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