Breast Cancer Female
Conditions
Keywords
Metformin, Breast cancer, IGF
Brief summary
The purpose of this study is to examine the impact of metformin as an adjuvant to chemotherapy on IGF levels in both progressing and non progressing cases of metastatic breast cancer in female patients.
Detailed description
One hundred and seven women with metastatic breast cancer (MBC) are randomly assigned to either a metformin (500 mg twice daily) or placebo (placebo) group during chemotherapy. All patients followed the standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI). Blood IGF-1 levels were measured at the start of treatment (baseline) and again six months later.
Interventions
MetFORMIN 500 Mg Oral Tablet
DRUGChemotherapy
The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female patients with MBC * patients older than 18 * nondiabetic patients * patients who received only chemotherapy
Exclusion criteria
* patients with non-metastatic breast cancer * patients receiving hormonal therapy or radiotherapy * patients with diabetes * history of cardiac diseases * hypersensitivity, or allergy to metformin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1 levels | 6 months. | IGF-1 levels were measured before and after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | 1 Year | The measurement values of IGF were divided into two groups, high and low, based on the cut off value. After a year of observation, researchers in both groups compared their progression-free survival (PFS). |
Countries
Egypt
Outcome results
None listed