NCT03941743

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Fingolimod	Given PO
DRUG	Fingolimod Hydrochloride	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-12-12
• Primary completion: 2020-06-05
• Completion: 2021-11-23
• First posted: 2019-05-08
• Last updated: 2023-07-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study