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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03941743

Recruitment Status Recruiting

First Posted May 8, 2019

Last update posted August 5, 2020

Study Description

Brief 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.

  • Condition or Disease:Breast Carcinoma
  • Intervention/Treatment: Drug: Fingolimod
    Drug: Fingolimod Hydrochloride
    Other: Questionnaire Administration
  • Phase: Phase 1
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Prevention
  • Official Title: Prevention of Paclitaxel-Associated Neuropathy With Fingolimod: a Pilot Trial
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Prevention (fingolimod hydrochloride)
Patients receive fingolimod hydrochloride PO QD starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks.
Drug: Fingolimod
Given PO

Drug: Fingolimod Hydrochloride
Given PO

Other: Questionnaire Administration
Ancillary studies
Outcome Measures
  • Primary Outcome Measures: 1. Serially measured total sensory neuropathy scores [ Time Frame: Baseline up to 18 months ]
    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 one-sample Wilcoxon signed-rank test will be considered as alternative approaches.
  • Secondary Outcome Measures: 1. Incidence of adverse events (AEs) [ Time Frame: Up to 18 months ]
    Scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0. Will be summarized by reporting the number and percentage of patients. The maximum grade for each type of AE will be recorded for each patient and data listings and frequency tables will be clinically reviewed to determine overall patterns, including AE attribution (possible, probable, and definite) to fingolimod. Additionally, the number and percentage of patients experiencing sensory neuropathy as defined by NCI CTCAE v5.0 will be tabulated by grade (none, mild, moderate, and severe); the proportion of patients experiencing >= grade 2 (moderate) CTCAE sensory neuropathy will estimated with the exact 90% confidence interval.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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 = 450 ms (on electrocardiography [EKG]).

- Concurrent use of a class Ia or III antiarrhythmic.

- Drugs with a known risk of torsades de pointes.

- Concurrent use of beta blockers, calcium channel blockers or digoxin.

- Use of immunosuppressive, or immune-modulating therapies that may have
immunosuppressive effects.

- Immunocompromised patients including patients known to be human immunodeficiency virus
(HIV) positive.

- Uncontrolled intercurrent illness including, but not limited to:

- Ongoing or active infection

- Unstable angina pectoris

- Cardiac arrhythmia

- Or psychiatric illness/social situations that would limit compliance with study
requirements.

- Receiving any other investigational agent.

- Family history of a genetic/familial neuropathy.

- Received a vaccine (inactivated) =< 14 days prior to registration.

Contacts and Locations
Contacts
Locations

United States, Minnesota
Mayo Clinic
Rochester

United States, Virginia
Virginia Commonwealth University/ Massey Cancer Center
Richmond

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Principal Investigator: Charles L Loprinzi Mayo Clinic

More Information
  • Responsible Party: Mayo Clinic
  • ClinicalTrials.gov Identifier: NCT03941743 History of Changes
  • Other Study ID Numbers: MC18C1, NCI-2019-02741, MC18C1, P30CA015083
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: August 5, 2020
  • Last Verified: August 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Breast Neoplasms