Family history of breast cancer
Conditions
Interventions
The first part of the study will be stratified in statistical analyzes of two cohorts of up to 19 well-determined patients: i) Cohort 1, formed by patients treated with drugs of the Taxane class
and ii) Cohort 2, formed by patients treated with drugs from the other classes. All patients will receive PSP NEURO SERUM (topical formulation) three times a day for 28 days, or until disease progress
ii) Phase 2 will consider up to 19 patients from each cohort (7 additional patients) and will seek at least 4 responses in total to consider the drug as active in each cohort. In addition, we will eva
C04.557.470.200.240.187
A05.360.319
Sponsors
Oncoclinicas do Brasil Serviços Médicos S.A
Oncoclinicas do Brasil Serviços Médicos S.A
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histological diagnosis of breast cancer, cervical cancer, uterine body cancer or ovarian cancer; Treatment with paclitaxel (taxol) in neoadjuvancy, adjuvancy or metastatic scenario; Grade = 2 peripheral sensory neuropathy by NCI-CTCAE version 5.0; Diagnosis of sensory peripheral neuropathy during treatment with paclitaxel (taxol) or up to 2 weeks after the last infusion of paclitaxel (taxol); Patients with chronic symptoms related to peripheral sensory neuropathy who finished treatment with paclitaxel (taxol) more than 2 weeks ago; Patients using neuropathic pain modulators will be allowed if the use is for any other reason and if there have been no dose adjustments in the past 2 weeks.
Exclusion criteria
Exclusion criteria: Patients receiving systemic treatment who have peripheral neuropathy among their common side effects (> 1%), or who have received the same in the last 2 weeks; Participating women who are pregnant; History of peripheral sensory neuropathy attributed to causes other than the use of anti-neoplastic agents; Patients with suspected or known allergy to seafood; History of alcoholism;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the improvement of tactile sensation through the Semmes-Weinstein monofilament test; ;Avaliar segurança; tipo, frequência, gravidade e causalidade dos efeitos adversos; do PSP NEURO SERUM; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess the improvement of the general neurological examination as assessed by the clinical version of the Total Neuropathy Score (TNSc - Total Neuropathy Score, Appendix 1); ;Evaluate the improvement in handling skills and agility as evaluation through NHPT (Nine-hole Pegboard Test - test of nine pins and holes); ;Assess the improvement of symptoms reported by the patient as assessed by the Patient Neuropathy Questionnaire (PNQ - Patient Neuropathy Questionnaire, Appendix 2); ;Assess safety and toxicity according to NCI-CTCAE v5.0 (National Cancer Institute - Commun Toxicity Criteria For Adverse Events). Adverse events will be collected weekly and in the security / follow-up visit; ;Evaluate the improvement in quality of life using the Brazilian Portuguese version of EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire - 30 items). | — |
Countries
Brazil
Contacts
Public ContactMariane Dias
Outcome results
None listed