drugset / Trial / NCT04137107
Duloxetine to Prevent Oxaliplatin-Induced Peripheral Neuropathy in Patients With Stage II-III Colorectal Cancer
Phase 2/3
Active not recruiting
220 enrolled
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI) · collab
RandomizedSequentialDouble-blindSupportive care
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.
Timeline
- Start
- 2020-06-17
- Primary completion
- 2026-02-28
- Completion
- 2026-12-31
Publications
- Cho Y, Scott MR, Wilson CM, Daniel M, Odii CO, Wang HL, Carlee J, Kreider J, Smith EML. Nurse Liaison Support to Safeguard the Scientific Rigor of Multisite Clinical Trials: Qualitative Findings From Communications Between Clinical Research Professionals. Cancer Nurs. 2025 Jul 30:10.1097/NCC.0000000000001528. doi: 10.1097/NCC.0000000000001528. Online ahead of print.
- Cho Y, Lavoie Smith EM, Zahrieh D, Chow SL, Williams DA, Saint Arnault D, Jiang Y. Electronic Patient-Reported Outcome Data Collection Systems in Oncology Clinical Trials: A Survey of Clinical Research Professionals (an Alliance Study). JCO Clin Cancer Inform. 2023 Sep;7:e2300007. doi: 10.1200/CCI.23.00007.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Duloxetine | Small molecule | 30 mg | Oral |
| Subject | Duloxetine | Small molecule | 60 mg | Oral |
| Background | Oxaliplatin | Small molecule | — | — |