Linaclotide for Colorectal Cancer

This trial tests linaclotide, a small protein, to evaluate its effectiveness in treating stages 0-3 colorectal cancer. Linaclotide prompts intestinal cells to release water and salt, potentially impacting cancer treatment. Participants will receive either linaclotide or a placebo (a harmless pill with no active ingredients) and will undergo standard procedures like colonoscopy or surgery after a week. Ideal participants are those diagnosed with stage 0-3 colorectal cancer or those who have had one or more colorectal polyps found in previous exams and are scheduled for surgery. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in cancer treatment.

The trial does not specify if you need to stop taking your current medications, but if you are on chronic anti-coagulants or non-NSAID anti-platelet agents, you may need to stop them if they can't be safely discontinued before study procedures.

Research shows that linaclotide is generally safe and well-tolerated. It has proven effective and safe for older adults, though some people might experience diarrhea as a side effect. Linaclotide also helps clean the bowels and has shown potential in detecting early signs of colon cancer.

Unlike the standard treatments for colorectal cancer that typically involve chemotherapy, radiation, or surgery, linaclotide is unique because it works by targeting the intestinal environment. Linaclotide, primarily used to treat irritable bowel syndrome, works by increasing fluid secretion in the intestine, which may improve the bowel's health and function. Researchers are excited about its potential to offer a novel, less invasive option that could complement or enhance the effectiveness of existing treatments. Additionally, linaclotide's oral administration makes it a convenient option for patients compared to more invasive treatments.

Research has shown that linaclotide can help prepare the bowel for procedures like colonoscopies. It improves bowel cleanliness, aiding doctors in identifying issues more clearly during exams. One study found that linaclotide increased the detection of polyps, which are growths in the colon that can become cancerous if untreated. This trial will compare linaclotide with a placebo to evaluate its effectiveness in spotting potential problems early, supporting colorectal health. While linaclotide doesn't directly treat colorectal cancer, it shows promise in assisting with procedures related to colorectal health.³⁶⁷⁸⁹