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COMPLETEDPHASE1

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

Prevention of Paclitaxel-Associated Neuropathy With Fingolimod: a Pilot Trial

NCT03941743•Mayo Clinic

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.

Detailed Description

PRIMARY OBJECTIVES: I. To obtain preliminary data to support whether fingolimod hydrochloride (fingolimod) will prevent chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving weekly adjuvant/neoadjuvant paclitaxel therapy. SECONDARY OBJECTIVES: I. To obtain pilot data regarding the possible relative toxicities related to fingolimod therapy in this study situation. OUTLINE: Patients receive fingolimod hydrochloride orally (PO) once daily (QD) starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks. After the completion of study, patients are followed up at 6, 12, and 18 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Ability to complete questionnaires by themselves or with assistance.
•Paclitaxel at a dose of 80 mg/m\^2 given every week for a scheduled course of 12 weeks for treating breast cancer.
•Life expectancy \>= 6 months.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1.
•Negative pregnancy test (serum or urine) done =\< 14 days prior to registration, for persons of childbearing potential only.
•Provide written informed consent.

Exclusion Criteria

•Previous exposure to paclitaxel (please note that it is acceptable for patients to receive non-neurotoxic chemotherapy, like doxorubicin hydrochloride (Adriamycin) and cyclophosphamide (AC), before or after the weekly paclitaxel and/or to receive concurrent anti-her 2 therapy).
•Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
•* Pregnant persons
•* Nursing persons
•* Persons of childbearing potential who are unwilling to employ adequate contraception.
•Previous diagnosis of diabetic or other peripheral neuropathy.
•Current or previous use of fingolimod.
•History of the following preexisting conditions: ischemic heart disease, cardiac arrest, cerebrovascular disease, uncontrolled hypertension, symptomatic bradycardia, macular edema, recurrent syncope, severe untreated sleep apnea, herpes simplex virus (HSV), varicella zoster virus (VZV), chronic hepatitis, tuberculosis, fungal infections, skin cancer, or diabetes.
•Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or class III/IV heart failure \< 6 months prior to registration.
•History or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker.
+15 more criteria

Locations (3)

Mayo Clinic

Rochester, Minnesota, United States

The Ohio State University

Columbus, Ohio, United States

Virginia Commonwealth University/ Massey Cancer Center

Richmond, Virginia, United States

Key Dates

Start Date

December 12, 2019

Primary Completion Date

June 5, 2020

Completion Date

November 23, 2021

Last Updated

July 21, 2023

Enrollment

ACTUAL participants

Conditions

Breast Carcinoma

Interventions

Fingolimod

DRUG

Fingolimod Hydrochloride

DRUG

Questionnaire Administration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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