Health Condition 1: null- Postmenopausal Nonmetastatic Breast Cancer Patients
Conditions
Interventions
Intervention1: Injection Hydroxyprogesterone: The subject will be administered Inj Hydroxy progesterone intramuscularly at defined time points as below:
Paclitaxel Chemotherapy regimen
Three Weekly
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1 Post-menopausal women up to 75 years of age. 2 Breast cancer patients with clinically operable or locally advanced stage of disease being planned for taxane based chemotherapy in the adjuvant or neoadjuvant setting. 3 Patients with adequate baseline marrow function defined as ANC > 1500/mm3 and Platelet count > 1, 00,000/mm3. 4 Patients with acceptable liver function tests (normal bilirubin and AST/ALT 5 Patients willing to provide informed consent. 6 Patients fit for chemotherapy with adequate cardiac reserve (defined as baseline LVEF >40%) 7 Taxane naive patients.
Exclusion criteria
Exclusion criteria: 1 Inflammatory breast cancer patients. 2 Pre-existent neuropathy (e.g. diabetes neuropathy, plexopathy, alcohol, toxin, hereditary or any other cause) of any grade. 3 Patients with presence of neuropathic pain or peripheral polyneuropathy or identified causes of painful paresthesia including radiotherapyâ??induced or malignant plexopathy, lumbar or cervical radiculopathy existing prior to baseline. 4 Patients with a prior history of any malignancy. 5 Uncontrolled hypertension or other cardiac abnormalities. 6 Patients who are illiterate compromising their ability to fill out the CIPN questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the cumulative incidence of grade II-IV paclitaxel chemotherapy induced peripheral neuropathy (CIPN), measured by the CTCAE Version 4 in the two randomized groups, 8 weeks after the last cycle of paclitaxel chemotherapy.Timepoint: Upto 8 weeks after the last cycle of paclitaxel chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Cumulative incidence (up to 8 weeks after the last dose of paclitaxel) of grade I CIPN measured by the CTCAE Ver. 4, in the two randomized groups.Timepoint: Upto 8 weeks after the last cycle of paclitaxel chemotherapy.;2. Cumulative incidence (up to 8 weeks after the last dose of paclitaxel) of grade III-IV, hematological and non-hematological (other than CIPN) toxicity, measured by the CTCAE Ver. 4, in the two randomized groups.Timepoint: Upto 8 weeks after the last cycle of paclitaxel chemotherapy.;3.Cumulative incidence (up to 8 weeks after the last dose of paclitaxel) of Grade II-IV CIPN in the different Taxane schedules measured by the CTCAE ver. 4.Timepoint: Upto 8 weeks after the last cycle of paclitaxel chemotherapy.;4. Pathological complete response rates in those patients with breast cancer who will receive neoadjuvant chemotherapy with hydroxy-progesterone.Timepoint: Upto 8 weeks after the last cycle of paclitaxel chemotherapy.;5.Disease free survival in the two randomized groupsTimepoint: At 5 years;6. Overall survival in two randomized groupsTimepoint: Overall survival is the time from the date of randomization until the date of death, censored at the last known date alive. | — |
Countries
India
Contacts
Public ContactDr Vani Parmar
Tata Memorial Hospital
Outcome results
None listed