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

Source: https://onco.cc/trials/nct04137107/  
OnCo record `nct04137107` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2/3 trial of fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Alliance for Clinical Trials in Oncology, active but no longer recruiting.

## Summary

Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer is a phase 2/3, randomised interventional study registered as NCT04137107 by Alliance for Clinical Trials in Oncology, with a registry enrolment figure of 220 participants, started 2020-06-17 and due to reach its primary completion in 2026-02-28. Interventions recorded: Oxaliplatin; Duloxetine Hydrochloride; Duloxetine; Quality-of-Life Assessment; Questionnaire Administration; Placebo. Conditions listed: Stage II Colorectal Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8. Primary outcome: Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase II); Prevention of sensory oxaliplatin-induced peripheral neuropathy (OIPN) response (Phase III); Chronic neuropathic pain response (Phase III). Colorectal eligibility wording from the registry: "* 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\^". Sites: Guam, United States. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT04137107
- Phase: 2/3
- Setting: Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III Study
- Sponsor: Alliance for Clinical Trials in Oncology
- Enrolled: 220

## Sources

- ClinicalTrials.gov NCT04137107: https://clinicaltrials.gov/study/NCT04137107

## Connected records

- cancers: [Colon cancer (adenocarcinoma of the colon)](https://onco.cc/cancers/colon-cancer/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/)
- companies: [Alliance for Clinical Trials in Oncology](https://onco.cc/companies/alliance-oncology/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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