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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07403071

Enrollment

200

Registered

2026-02-11

Start date

2026-05-01

Completion date

2027-12-31

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Peripheral Neuropathy Due to Chemotherapy

Brief 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.

Interventions

DIETARY_SUPPLEMENTFish 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Grading of Peripheral Neuropathy according to NCI-CTCAE criteria	From enrollment to the end of treatment at 24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026