Active — Not RecruitingPhase 2/3

Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer

United States, Guam220 participantsStarted 2020-06-17

Plain-language summary

This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy.

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* Stage II-III colorectal cancer patients scheduled to receive oxaliplatin 510 mg/m\^2 (cumulative dose) over 12 weeks as a component of adjuvant leucovorin calcium (calcium folinate), 5-fluorouracil and oxaliplatin (FOLFOX) treatment, in which patients are scheduled to receive oxaliplatin 85 mg/m\^2 every 2 weeks for 12 weeks (i.e., 6 cycles), or adjuvant capecitabine and oxaliplatin (CAPOX) treatment, in which patients are scheduled to receive oxaliplatin 135 mg/m\^2 every 3 weeks for 12 weeks (i.e., 4 cycles) * No prior neurotoxic chemotherapy * No pre-existing clinical or pre-clinical peripheral neuropathy from any cause. * No history of seizure disorder, * No history of narrow-angle glaucoma. * No symptoms of or history of schizophrenia, bipolar disease, suicidal thoughts and/or a major depression. * No serious eating disorder such as bulimia or anorexia. * No known diagnosis of ethanol (ETOH) addiction/dependence within the past 10 years. * Concomitant medications: * No concomitant use of other adjuvant pharmacologic interventions (e.g., gabapentin, pregabalin, venlafaxine) with known or hypothesized efficacy for peripheral neuropathy. Must be discontinued at least 7 days prior to start of protocol treatment * No anticipated or concurrent use of any antidepressant or serotonin-altering agent known to interact with duloxetine, due to concern regarding cumulative toxicity and potential drug interactions. * Use of a monoamine oxidase inhibitor (MAOI) or other antide…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II)

Timeframe: Up to 1 month post-oxaliplatin treatment

Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III)

Timeframe: Up to 1 month post-oxaliplatin treatment

Chronic neuropathic pain response (Phase III)

Timeframe: Up to 1 month after oxaliplatin treatment

Trial details

NCT IDNCT04137107

SponsorAlliance for Clinical Trials in Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28

View on ClinicalTrials.gov More Stage II Colorectal Cancer AJCC v8 trials

Plain-language summary

Who can participate

Age range

25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II)

Timeframe: Up to 1 month post-oxaliplatin treatment

Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III)

Timeframe: Up to 1 month post-oxaliplatin treatment

Chronic neuropathic pain response (Phase III)

Timeframe: Up to 1 month after oxaliplatin treatment