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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple myeloma patients with bortezomib-induced peripheral neuropathy who are receiving oral fish |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Grading of Peripheral Neuropathy according to NCI-CTCAE criteria | From enrollment to the end of treatment at 24 weeks |
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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:
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Patients who had no baseline peripheral neuropathy before bortezomib treatment, developed peripheral neuropathy following bortezomib therapy, and subsequently received fish oil.
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|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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