Could a constipation drug help fight colorectal cancer?
NCT ID NCT03796884
First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times
Summary
This Phase 2 trial is testing whether linaclotide, a drug currently used for constipation, can slow or prevent colorectal cancer growth. About 150 people with colorectal polyps or early-stage cancer will take the drug or a placebo before surgery. Researchers will measure changes in cell signals and tumor markers to see if the drug has a biological effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- linaclotide
- What this could lead to
- If it works, this could point toward a new way to slow or prevent colorectal cancer growth using a drug already approved for other conditions.
- What could go wrong
- This is an early Phase 2 trial with only 150 participants, so results may not apply broadly. The drug may not show enough effect on tumor markers to justify larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
150 people
The number who actually took part.
- Started
-
Oct 2019
- Expected to finish
-
Sep 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * History of 1 or more sporadic colorectal adenoma on previous endoscopy (adenoma cohort) or stage 0-3 biopsy proven colorectal cancer (CRC) (colorectal cancer cohort) who are scheduled for a surgical procedure * Ability to understand and willingness to sign a written informed consent document and follow study procedures * Ability to swallow capsules without difficulty * Ability to maintain pill diaries * Willingness to employ adequate contraception for men and women of childbearing potential for the duration of the study. Acceptable methods include double barrier methods, intrauterine device (IUD), postmenopausal status, and/or documentation of surgical sterilization * Participants must have no chronic, clinically severe health issues which, in the opinion of their physician or the research team, could preclude trial activities including the one week drug exposure phase Exclusion Criteria: * History of gastroparesis * History of celiac disease * Inflammatory bowel disease (Crohn's disease, ulcerative colitis) * Microscopic colitis, including collagenous colitis * Has taken linaclotide within 30 days prior to consent * Any malignancy except colorectal cancer or any active radiotherapy or cytotoxic chemotherapy within the last 6 months of baseline. Participants with a history of basal cell or squamous cell skin cancer may be enrolled at the discretion of the investigator * Participants may not be receiving any other investigational agents, or be active participants in any clinical trials. If participants previously participated in a clinical trial, a 30 day washout period for the investigational drug is needed before the participant can be considered for this study * History of allergic reactions attributed to compounds of similar chemical or biologic composition to linaclotide * Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or lactating women * History of bleeding/coagulation problems. Concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs) including aspirin is acceptable * Any medical condition judged by the investigator to constitute a risk to safe participation * At risk for obstructing or near-obstructing mechanical gastrointestinal obstruction * Chronic use of anti-coagulants or non-NSAID anti-platelet agents will serve as an exclusion only when such medications cannot be safely discontinued before study related endoscopy or surgery
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal adenoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
-
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19126, United States
-
VA Puget Sound Health Care Sysem
Seattle, Washington, 98108, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a vaccine stop GI cancers from returning?
- AI measures bowel cleanliness to boost polyp detection
- AI may catch precancerous polyps from simple blood tests
- AI eyes colon polyps: can it spot the dangerous ones?
- Can beans beat obesity and colon cancer?
- Can 3D vision spot hidden polyps better than standard colonoscopy?