IGF Level in Breast Cancer Patients Treated With Metformin

Beni-Suef University

Status and phase: Completed; Phase 4

Conditions: Breast Cancer Female

Treatments: Drug: Chemotherapy; Drug: MetFORMIN 500 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05840068

IGF level in breast cancer

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Metformin and Chemotherapy

Experimental group

Description:

Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)

Treatment:

Drug: MetFORMIN 500 Mg Oral Tablet

Drug: Chemotherapy

Chemotherapy alone

Other group

Description:

Chemotherapy is administered alone to Group B (n=50).

Treatment:

Drug: Chemotherapy