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NCT03941743 · ClinicalTrials.gov registry record · Phase 1

Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer

A Phase 1 study, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
2
Enrollment target

NCT03941743: Completed Phase 1 study, sponsored by Mayo Clinic.

NCT03941743 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03941743, a Phase 1 study, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

This trial phase I studies how well fingolimod works in preventing chemotherapy-induced nerve pain (neuropathy) in patients with breast cancer who are taking paclitaxel. Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by paclitaxel.

Primary Outcome

Obtained from the 6 individual Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN)20 questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet). The hypothesis will be tested with the two-sided one sample t-test at a significance level of 10%. In the event that the distribution of the patient?s average total sensory neuropathy scores is not approximately normally distributed, then variable transformation or a nonparametric

Interventions

  • OTHER Questionnaire Administration
  • DRUG Fingolimod
  • DRUG Fingolimod Hydrochloride

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2019-12-12
Est. Completion 2021-11-23
Phase Phase 1
Mayo Clinic

2,844 total trials

What the finished NCT03941743 record still lists

NCT03941743 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Questionnaire Administration is the first listed.

NCT03941743 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03941743 about?

NCT03941743 is a clinical study titled "Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer". This trial phase I studies how well fingolimod works in preventing chemotherapy-induced nerve pain (neuropathy) in patients with breast cancer who are taking paclitaxel. Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy ...

What is the current status of trial NCT03941743?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2019-12-12. Estimated completion is 2021-11-23.

What interventions are being tested in trial NCT03941743?

The interventions under investigation include: Questionnaire Administration (OTHER), Fingolimod (DRUG), Fingolimod Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT03941743?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03941743's enrollment target sits among peer trials

2 2000th of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03941743, the US trial registry maintained by the National Library of Medicine. NCT03941743 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.