Multiple MyelomaNCT07403071
Validating Fish Oil's Role in Alleviating Bortezomib-Induced Neuropathy: A Multi-Method Study Integrating Big Data, Experimental, and Clinical Research
An observational study of Multiple Myeloma and Peripheral Neuropathy Due to Chemotherapy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Peripheral Neuropathy Due to Chemotherapy
- What is being tested?
- Fish Oil (Containing Omega-3 Acids)
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2027
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had no baseline peripheral neuropathy before bortezomib treatment, developed peripheral neuropathy following bortezomib therapy, and subsequently received fish oil.
Who may be able to join
- (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.
- Absence of baseline peripheral neuropathy prior to the initiation of bortezomib treatment.
- Provision of signed informed consent.
Who cannot join
- (1) Patients with poor medication adherence. (2) Women who are pregnant or lactating. (3) Cases deemed ineligible by the investigator.
About this study
Official 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
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?
Read the 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.
- Being tested
- Fish Oil (Containing Omega-3 Acids)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiple myeloma patients with bortezomib-induced peripheral neuropathy who are receiving oral fish | Not described Receives: Dietary Supplement: Fish Oil (Containing Omega-3 Acids) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grading of Peripheral Neuropathy according to NCI-CTCAE criteria
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403071
- Sponsor's protocol ID
- 2024-218-01
- Status last verified
- Oct 2025
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07403071
- Acronym / sponsor ID
- 2024-218-01
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple myeloma patients with bortezomib-induced peripheral neuropathy who are receiving oral fish | – | Dietary Supplement: Fish Oil (Containing Omega-3 Acids) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had no baseline peripheral neuropathy before bortezomib treatment, developed peripheral neuropathy following bortezomib therapy, and subsequently received fish oil.
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (1 listed)
- (1) Patients with poor medication adherence. (2) Women who are pregnant or lactating. (3) Cases deemed ineligible by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Multiple myeloma patients with bortezomib-induced peripheral neuropathy who are receiving oral fish |
Primary outcome
Grading of Peripheral Neuropathy according to NCI-CTCAE criteria
Time frame: From enrollment to the end of treatment at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Peripheral Neuropathy Due to Chemotherapy, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grading of Peripheral Neuropathy according to NCI-CTCAE criteria (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.