Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy (NCT07082764) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy
France30 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female, who is at least 18 years of age or older
* Patients with clinical diagnosis of breast cancer
* Patients planned to be treated with paclitaxel or docetaxel
* Patients who can understand and sign the Informed Consent Form
* Patients who can apply the study gel by himself /herself or has a giver that can apply the product.
* Female patients of childbearing potential who agree to use a highly effective method of contraception throughout the study
Exclusion Criteria:
* Patient already treated with taxanes or other chemotherapies known to induce neuropathies
* Patient with previously diagnosed peripheral neuropathy
* Patient with concomitant therapies known to induce neuropathies
* Patient treated for neuropathic pain
* Patient with comorbid factors known to induce neuropathies (such as Diabetes, Alcoholism, HIV, Peripheral vascular disease, Vitamin B deficiencies)
* Patient currently receiving monoamine oxidase (MAO) inhibitors therapy or patients on antidepressants which affect noradrenergic transmission e.g. tricyclic antidepressants and mianserin (as mentioned in the current topical brimonidine labeling of approved products).
* Patient who will not be able to follow the protocol for physical or psychological reasons
* Patient with history of skin disorders, significant skin disease, irritated skin or open wounds within the same body areas planned for the IMP application.
* Known or suspected allergies or sensitivities to any components o…
What they're measuring
1
Number of treatment related local adverse events
Timeframe: From Baseline up to the end of 12 taxane perfusions