Spots Global Cancer Trial Database for Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer

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Trial Identification

Brief Title: Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer

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

Study ID: NCT03941743

Conditions

Breast Carcinoma

Interventions

Fingolimod

Fingolimod Hydrochloride

Questionnaire Administration

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.

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.