NCT07403071

Validating Fish Oil's Role in Alleviating Bortezomib-Induced Neuropathy: A Multi-Method Study Integrating Big Data, Experimental, and Clinical Research

A Study Combining Big Data Mining With Experimental and Clinical Research to Validate the Alleviating Effect of Fish Oil on Bortezomib-Induced Peripheral Neuropathy

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to find out if taking fish oil by mouth can help prevent or lessen a side effect called peripheral neuropathy in patients who are being treated with the chemotherapy drug bortezomib. We are mainly looking to answer one question: Can fish oil reduce the chances of getting this nerve damage, or make it less severe, for these patients?

Detailed description

* To understand the incidence of bortezomib-induced peripheral neuropathy (PN) and the resulting rates of treatment discontinuation and dose reduction, a real-world retrospective study will be conducted. * Potential preventive drugs for bortezomib-induced PN will be identified by mining the FDA Adverse Event Reporting System (FAERS) database. * The preventive effects of the candidate drugs against bortezomib-induced PN will be validated through in vivo and in vitro experiments. * A prospective, randomized controlled trial will be performed to confirm the efficacy of the candidate drugs in preventing bortezomib-induced PN.

Conditions

• Multiple Myeloma
• Peripheral Neuropathy Due to Chemotherapy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fish Oil (Containing Omega-3 Acids)	The patients were followed up every two months to assess whether they subjectively felt an alleviation of peripheral neuropathy. The severity of peripheral neuropathy was objectively evaluated using the CTCAE criteria and the EORTC QLQ-CIPN20 scale.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-11
• Last updated: 2026-02-11