Duloxetine for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether duloxetine, commonly used for depression and pain, can prevent pain, tingling, and numbness in patients with stage II-III colorectal cancer receiving the chemotherapy drug oxaliplatin. Duloxetine increases certain chemicals in the brain. The trial includes different groups to determine the best dose and assess effectiveness. It suits patients with colorectal cancer who will receive oxaliplatin and have not experienced similar nerve issues before. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing patients to contribute to important research.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. You cannot use other drugs for peripheral neuropathy, certain antidepressants, or serotonin-altering agents. Some medications must be stopped at least 7 to 14 days before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that duloxetine is generally safe for use. It often helps with pain and symptoms like tingling and numbness associated with chemotherapy. Studies indicate that duloxetine is sometimes used off-label to treat nerve pain from cancer treatments with drugs like paclitaxel and docetaxel. This suggests it might also help with similar symptoms from other cancer treatments like oxaliplatin.
Duloxetine has been tested on many people, and most can take it without serious issues. However, like any medication, it can have side effects. Some people experience nausea, dry mouth, or tiredness. Rarely, it may cause more serious problems, so regular check-ups during treatment are important.
The FDA addressed a recall due to a possible cancer-causing chemical in one batch, but this was a specific issue. Discussing any concerns with a doctor is always advisable, but overall, duloxetine's safety is well understood from years of use.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for colorectal cancer, which typically involve chemotherapy, radiation, and surgery, duloxetine is primarily known as an antidepressant and works by influencing serotonin and norepinephrine in the brain. Researchers are excited about duloxetine for colorectal cancer because it offers a novel approach to potentially managing symptoms or enhancing quality of life for patients, which traditional cancer treatments may not address directly. Additionally, if duloxetine demonstrates effectiveness in this new role, it could provide a less invasive treatment option with a different side effect profile compared to conventional cancer therapies.
What evidence suggests that duloxetine could be effective in preventing peripheral neuropathy in colorectal cancer patients?
This trial will evaluate duloxetine's effectiveness in preventing chemotherapy-induced peripheral neuropathy (CIPN) in colorectal cancer patients. Studies have shown mixed results regarding duloxetine's ability to prevent CIPN, which includes symptoms like pain, tingling, and numbness. Research suggests that duloxetine can help manage pain and aid recovery after some surgeries. However, other studies found duloxetine no more effective than a placebo in preventing tingling and numbness from chemotherapy. It increases certain brain chemicals that help reduce pain and depression. While some evidence supports its use for pain relief, its effectiveness in preventing CIPN remains uncertain. Participants in this trial will be assigned to different groups, including those receiving duloxetine and those receiving a placebo, to further investigate its potential benefits.12678
Who Is on the Research Team?
Ellen M. Lavoie Smith, PhD
Principal Investigator
The University of Alabama at Birmingham School of Nursing
Are You a Good Fit for This Trial?
This trial is for stage II-III colorectal cancer patients who are about to receive oxaliplatin treatment and have no prior neurotoxic chemotherapy, pre-existing neuropathy, seizure disorders, glaucoma, severe psychiatric conditions or substance abuse. They must not be on certain medications like MAOIs or strong CYP1A2 inhibitors and should not be pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive duloxetine or placebo alongside standard oxaliplatin treatment to prevent peripheral neuropathy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Duloxetine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance for Clinical Trials in Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator