Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03941743|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : January 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Carcinoma||Drug: Fingolimod Drug: Fingolimod Hydrochloride Other: Questionnaire Administration||Phase 1|
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.
I. To obtain pilot data regarding the possible relative toxicities related to fingolimod therapy in this study situation.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Paclitaxel-Associated Neuropathy With Fingolimod: a Pilot Trial|
|Actual Study Start Date :||May 24, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
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 Hydrochloride
Other: Questionnaire Administration
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941743
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Charles L. Loprinzi 507-284-2511|
|Principal Investigator: Charles L. Loprinzi|
|United States, Virginia|
|Virginia Commonwealth University/ Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Gwendolyn Parker, FNP-C 804-828-5090 Masseycpc@vcu.edu|
|Principal Investigator: Zhi-Jian Chen, MD|
|Principal Investigator:||Charles L Loprinzi||Mayo Clinic|