Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy
Condition(s) studied
Investigational drug(s) / intervention(s)
Brimonidine gel: TAR-0520 gel
No intervantion: No treatment
Study summary
Taxane -induced peripheral neuropthy (TIPN) and nail toxicites are frequent side effects of taxane therapy in breast cancer patients.. TIPN involves the hands and the feet ,its symptoms comprise numbness,tingling,altered touch sensation, impaired vibration, parasthesia and dysesthesias induced by touch, warm or cool temperatures.
This study investigate the preventive effect of TAR-0520 gel on TIPN and on nail toxicity.
Breast cancer patients under taxanes therapy will apply TAR-0520 Gel to one hand and the homolateral foot including fingers and toes. Other hand and foot will be untreated and will serve as control.
Patients will be followed during the 12 cycles of taxane therapy. Evaluations of TIPN will include clinical assessments by the oncologist, examination by a neurologist, patient questionnaires administered by a nurse and objective neurophysiological measures conducted by trained personnel. Evaluation of taxane nail toxicity will include a clinical grading by a nurse and a patient questionnaire.
Eligibility
Primary outcome measure(s)
- Number of treatment related local adverse events — From Baseline up to the end of 12 taxane perfusions
Treatement related local adverse events inluding erythema, oedema, pruritus
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Institut Paoli-Calmettes | Marseille | France |
More Tarian Pharma trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07082764 on ClinicalTrials.gov ↗ ← All trials in France