Prevention of localised cutaneous side effects induced by chemotherapy Skin and Connective Tissue Diseases
Conditions
Interventions
All participants will receive TAR-0520 gel alongside their standard chemotherapy regimen.
Treatment Details
Chemotherapy Regimens:
Docetaxel every 3 weeks for 4 cycles
Docetaxel every 3 weeks for 6 c
Sponsors
TARIAN PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients 2. Cancer patients planned to be treated with taxane perfusions (docetaxel or paclitaxel) as part of their chemotherapy protocol. Any type of cancer requiring taxane treatment (breast, ovarian, prostate, urinary bladder, pancreatic or lung cancer) can be included. Taxane treatment can be the first or second line of treatment. 3. Patients, with or without metastasis, whose condition is considered stable and compatible with the participation to a clinical trial 4. Patients understand and agree to comply with the requirements of the clinical trial protocol. 5. Female patients of childbearing potential agree to use a highly effective method of contraception throughout the study. Highly effective method of contraception can be: - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) - progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) - intrauterine device (IUD) - intrauterine hormone-releasing system (IUS) - bilateral tubal occlusion - vasectomized partner - sexual abstinence
Exclusion criteria
Exclusion criteria: 1. Patients already treated with taxanes or other chemotherapies known to induce neuropathies in the past year 2. Patients with diagnosed peripheral neuropathy whatever its cause (Diabetes, Alcoholism, HIV, Peripheral vascular disease, Vitamin B deficiencies). Pre-diabetic patients without neuropathy can be included 3. Patients with concomitant therapies known to induce neuropathies 4. Patients treated for neuropathic pain 5. Patients who will not be able to follow the protocol for physical or psychological reasons 6. Patients 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). 7. Female who is pregnant or lactating 8. Female who intends to conceive a child during the clinical trial
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (AEs) collected through patient interviews and review of medical records at Day 1 (Week 1), Week 4, Week 7, Week 10, Week 13, Week 16, and at the follow-up visit 4 weeks after the last chemotherapy cycle 2. Physical examination (covering skin, lungs, abdomen, neurological function, musculoskeletal system, lymph nodes, cardiovascular system) conducted by the investigator at screening (Day -15), Day 1 (Week 1), and at the end of the study or early termination visit 3. Vital signs (systolic and diastolic blood pressure and pulse rate, measured after 5 minutes in sitting position) at screening visit, Day 1 (Week 1), Week 4, Week 7, Week 10, Week 13, Week 16, and at the follow-up visit 4 weeks after the last chemotherapy cycle | — |
Primary
| Measure | Time frame |
|---|---|
| Peripheral neuropathy symptoms measured using the modified Chemotherapy-Induced Peripheral Neuropathy (CIPN) Patient-Reported Outcome (PRO) questionnaire (hands and feet subscales) at Day 1 (Week 1), Week 4, Week 7, Week 10, Week 13, Week 16, and at the follow-up visit 4 weeks after the last chemotherapy cycle | — |
Countries
Mauritius
Contacts
Public ContactVimi Kolanthan
Outcome results
None listed