Safety and Efficacy Study of TAR-0520 Gel in Prevention of Taxane-induced Peripheral Neuropathy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTarian Pharma
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Brimonidine gel
DrugTAR-0520 gel
No intervantion
Other interventionNo treatment
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Intra-individual active comparator vs no interventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of treatment related local adverse events
Treatement related local adverse events inluding erythema, oedema, pruritus
Time frame
From Baseline up to the end of 12 taxane perfusionsSecondary outcomes
1
CTCAE grade of peripheral neuropathy
CTCAE V5.0 Nervous system disorders grading ( Grade 0-5, 0-asymptomatic, 5- death)
Time frame
From Baseline up to the end of 12 taxane perfusions2
Instrumental objective measures of TIPN - heat thresold
Quantitative sensory testing - heat thresold measurement at each hand and feet
Time frame
At Baseline and after 6th and 12th taxane perfusion3
Instrumental objective measures of TIPN - cold thresold
Quantitative sensory testing - cold thresold measure on each hand and feet
Time frame
At Baseline and after 6th and 12th perfusions4
Instrumental objective measures of TIPN - vibration treshold
Quanitative sensory testing - vibration treshold
Time frame
At Baseline and after 6th and 12th perfusionOther outcomes
1
Nail toxicity grading
Nail toxicity grading at each hand and foot : nail discoloration; nail riding; nail onycholysis - each graded as absent, mild, moderate or severe.
Time frame
At Baseline and before 4th and 12th perfusionSponsors and contacts
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Source ClinicalTrials.gov
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