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NCT05840068 Clinical Trial

IGF Level in Breast Cancer Patients Treated With Metformin

Breast Cancer Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05840068
Other study ID # IGF level in breast cancer
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 1, 2020
Est. completion date July 31, 2021

Study information
Verified date May 2023
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 107
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• MetFORMIN 500 Mg Oral Tablet
MetFORMIN 500 Mg Oral Tablet
• Chemotherapy
The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).

Locations
Country Name City State
Egypt Marian S. Boshra Bani Suwayf

Sponsors (1)
Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Essa NM, Salem HF, Elgendy MO, Gabr A, Omran MM, Hassan NA, Tashkandi HM, Harakeh S, Boshra MS. Efficacy of Metformin as Adjuvant Therapy in Metastatic Breast Cancer Treatment. J Clin Med. 2022 Sep 20;11(19):5505. doi: 10.3390/jcm11195505. — View Citation

Ko KP, Ma SH, Yang JJ, Hwang Y, Ahn C, Cho YM, Noh DY, Park BJ, Han W, Park SK. Metformin intervention in obese non-diabetic patients with breast cancer: phase II randomized, double-blind, placebo-controlled trial. Breast Cancer Res Treat. 2015 Sep;153(2):361-70. doi: 10.1007/s10549-015-3519-8. Epub 2015 Aug 21. — View Citation

Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536. Erratum In: Nat Rev Cancer. 2009 Mar;9(3):224. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary IGF-1 levels IGF-1 levels were measured before and after treatment. 6 months.
Secondary 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
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