None listed
Conditions
Interventions
Product Name: Promensil
Product Code: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: SOY ISOFLAVONES
CAS Number: 8000055-25-6
Current Sponsor code: NA
Other descriptive name: red clover isoflavon
Sponsors
NAMED SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients who have undergone surgery for breast cancer: he chose - T1-2N0-1M0 treated with tamoxifen more or less the same, more or less pre-operative adjuvant chemotherapy or - Patients who are premenopausal at the time of histological diagnosis - No cancer arising in pregnancy - Renal function, normal cardiac and respiratory - Complete blood count to normal - Adherence to the study with informed consent - People can take part in the study for the expected time - Score rating scale (MRS Menopausal Rating Scale) = 8 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Score rating scale (MRS Menopausal Rating Scale) = 8 - Women after natural menopause or induced at the time of surgery - A history of or concurrence of other primary malignancies except carcinoma in situ of the cervix and basal-cell carcinoma of the skin - Recurrence of breast cancer - Presence of distant metastases - Histology different from breast cancer epithelial - Lobular carcinoma in situ of the breast - Participating in other clinical trials, controlled trials that could interfere with the evaluation of the results of this study - Geographical inaccessibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: decrease of menapausal symptoms in women treated with tamoxifen for breast cancer after surgery;Secondary Objective: To evaluate the ability of serum of treated patients compared to patients not treated with phytoestrogens to alter the migratory ability of tumor cells in the presence of estradiol.;Primary end point(s): 1) Improving the quality of life by reducing symptoms of menopausal syndrome induced by antineoplastic treatment 2) Demonstration of toxicity and no additional treatment-related interference in the studio;Timepoint(s) of evaluation of this end point: total study duration: 2 years, 3 months after first detection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of estrogen on the serum of patients - Evaluating changes of migration of cell lines;Timepoint(s) of evaluation of this end point: 3 months from start of therapy | — |
Countries
Italy
Contacts
Public ContactResponsabile scientifico
Named Srl
Outcome results
None listed