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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

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

Trial population

Patients who had no baseline peripheral neuropathy before bortezomib treatment, developed peripheral neuropathy following bortezomib therapy, and subsequently received fish oil.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Multiple myeloma patients with bortezomib-induced peripheral neuropathy who are receiving oral fish1 intervention

Trial outcomes

Primary outcomes

1

Grading of Peripheral Neuropathy according to NCI-CTCAE criteria

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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