IGF Level in Breast Cancer Patients Treated With Metformin

NCT ID: NCT05840068

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-07-31

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.

Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin and Chemotherapy

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

Group Type EXPERIMENTAL

MetFORMIN 500 Mg Oral Tablet

Intervention Type DRUG

MetFORMIN 500 Mg Oral Tablet

Chemotherapy

Intervention Type DRUG

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

Chemotherapy alone

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

Group Type OTHER

Chemotherapy

Intervention Type DRUG

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

Interventions

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MetFORMIN 500 Mg Oral Tablet

MetFORMIN 500 Mg Oral Tablet

Intervention Type DRUG

Chemotherapy

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

Intervention Type DRUG

Other Intervention Names

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Glucophage 500 oral tablet and Chemotherapy Chemotherapy alone

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Marian S. Boshra

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marian S. Boshra

Banī Suwayf, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 26293146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36233373 (View on PubMed)

Pollak M. Insulin and insulin-like growth factor signalling in neoplasia. Nat Rev Cancer. 2008 Dec;8(12):915-28. doi: 10.1038/nrc2536.

Reference Type RESULT
PMID: 19029956 (View on PubMed)

Other Identifiers

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IGF level in breast cancer

Identifier Type: -

Identifier Source: org_study_id

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