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Paclitaxel

Albumin-Bound Paclitaxel

Fingolimod Hydrochloride

Immunosuppressive Agents

Immunologic Factors

Patients receive fingolimod hydrochloride PO QD starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks.

Fingolimod

Questionnaire Administration

Charles L Loprinzi

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.

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.

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

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

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.

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.

National Cancer Institute (NCI)

Mayo Clinic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer	NCT03941743	Breast Carcinom...	Fingolimod Fingolimod Hydr... Questionnaire A...	18 Years -	Mayo Clinic
Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer	NCT03941743	Breast Carcinom...	Fingolimod Fingolimod Hydr... Questionnaire A...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for fingolimod hydrochloride