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

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?

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Peripheral Neuropathy Due to Chemotherapy Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) Aged 18 years or older, regardless of gender. (2) Diagnosed with multiple myeloma (MM) according to the "Guidelines for the Diagnosis and Management of Multiple Myeloma," and scheduled to receive bortezomib as first-line therapy.

(3) Absence of baseline peripheral neuropathy prior to the initiation of bortezomib treatment.

(4) Provision of signed informed consent.

Exclusion criteria

(1) Patients with poor medication adherence. (2) Women who are pregnant or lactating. (3) Cases deemed ineligible by the investigator.

Treatment and study plan

Fish Oil (Containing Omega-3 Acids)

Dietary Supplement

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.

Primary outcomes

Grading of Peripheral Neuropathy according to NCI-CTCAE criteria

Time frame: From enrollment to the end of treatment at 24 weeks

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Feb 11, 2026
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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