IGF Level in Breast Cancer Patients Treated With Metformin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Drug: MetFORMIN 500 Mg Oral Tablet
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin and Chemotherapy<br>Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57) | Drug: MetFORMIN 500 Mg Oral Tablet<br>* MetFORMIN 500 Mg Oral Tablet<br>* Other names: Glucophage 500 oral tablet and Chemotherapy;Drug: Chemotherapy<br>* The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).<br>* Other names: Chemotherapy alone;|
| Other: Chemotherapy alone<br>Chemotherapy is administered alone to Group B (n=50). | Drug: Chemotherapy<br>* The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).<br>* Other names: Chemotherapy alone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 levels | IGF-1 levels were measured before and after treatment. | 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | 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). | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, Breast cancer, IGF