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Completed

NCT Number: NCT05840068

IGF Level in Breast Cancer Patients Treated With Metformin

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.

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Key information

Conditions

Breast Cancer Female Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Marian S. Boshra

Banī Suwayf, 62514, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MetFORMIN 500 Mg Oral Tablet

Drug

MetFORMIN 500 Mg Oral Tablet

Other names: Glucophage 500 oral tablet and Chemotherapy

Chemotherapy

Drug

The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).

Other names: Chemotherapy alone

Primary outcomes

  1. IGF-1 levels

    Time frame: 6 months.

    IGF-1 levels were measured before and after treatment.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 3, 2023
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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