Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: METFORMIN AND NEOADJUVANT OR PALLIATIVE CHEMOTHERAPY: 4-8 cycles of neoadjuvant chemotherapy or palliative chemotherapy will be given for all group of patients. Each cycle as a duration
Sponsors
SRM COLLEGE OF PHARMACY
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients will be included based on ECOG (Eastern Cooperative Oncology Group) Performance status scale (Only under Grade 0, 1, 2). 2. Patients newly diagnosed with ductal carcinoma and lobular carcinoma without diabetes mellitus. 3. Patients aged above 18 years. 4. Patients undergoing chemotherapy for newly diagnosed ductal carcinoma and lobular carcinoma in pre surgical conditions. 5. Patients undergoing palliative chemotherapy for the treatment of newly diagnosed stage-4 breast cancer.
Exclusion criteria
Exclusion criteria: 1. Patients will be excluded based on ECOG (Eastern Cooperative Oncology Group) Performance status scale (Above Grade 2). 2. Diabetes patients diagnosed with ductal carcinoma and lobular carcinoma and undergoing treatment. 3. Patients aged below18 years. 4. Patients on metformin therapy for other metabolic conditions such as diabetes, PCOS. 5. Patients receiving radiotherapy for ductal carcinoma and lobular carcinoma (except used to treat palliative pain, symptoms of breast cancer). 6. Patients with renal failure (GFR 7. Patients with brain metastases, severe ill patients in ICU with ductal carcinoma and lobular carcinoma. 8. Patients or legal representatives who are not willing to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in reduction of tumor size and numbers. Reduction in side effects and adverse events of chemo drugs. Non chemo drugs also can be used in the treatment of breast cancer. Timepoint: baseline 3rd month 6th month | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost of treatment can be reduced. Improvement in QoL of breast cancer patients. Survival rate of the patients may be increased. Timepoint: Cost will be analyzed from baseline to end of study. QoL will be calculated once a month till the end of study. Survival rate will be assessed from baseline to end of study. | — |
Countries
India
Contacts
Public ContactDr S SARUMATHY
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
Outcome results
None listed