IGF Level in Breast Cancer Patients Treated With Metformin

Phase 4

Completed

• Conditions: Breast Cancer Female
• Interventions: Drug: Chemotherapy; Drug: MetFORMIN 500 Mg Oral Tablet

• Registration Number: NCT05840068
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study Start: 2020-06-01
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy alone	Chemotherapy	Chemotherapy is administered alone to Group B (n=50).
Metformin and Chemotherapy	MetFORMIN 500 Mg Oral Tablet	Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)
Metformin and Chemotherapy	Chemotherapy	Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)

Primary Outcome Measures

Name	Time	Method
IGF-1 levels	6 months.	IGF-1 levels were measured before and after treatment.

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Marian S. Boshra; 🇪🇬 Banī Suwayf, Egypt