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

Who is this study for? Adult patients with breast cancer
What treatments are being studied? Fingolimod+Fingolimod Hydrochloride
Status: Completed
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic
Rochester
Ohio
The Ohio State University
Columbus
Virginia
Virginia Commonwealth University/ Massey Cancer Center
Richmond
Time Frame
Start Date: 2019-12-12
Completion Date: 2021-11-23
Participants
Target number of participants: 2
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov