Back to resultsIGF Level in Breast Cancer Patients Treated With Metformin
Primary Purpose
Breast Cancer Female
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
MetFORMIN 500 Mg Oral Tablet
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Female focused on measuring Metformin, Breast cancer, IGF
Eligibility Criteria
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.
Sites / Locations
- Marian S. Boshra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Metformin and Chemotherapy
Chemotherapy alone
Arm Description
Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)
Chemotherapy is administered alone to Group B (n=50).
Outcomes
Primary Outcome Measures
IGF-1 levels
IGF-1 levels were measured before and after treatment.
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05840068
Brief Title
IGF Level in Breast Cancer Patients Treated With Metformin
Official Title
Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Metformin, Breast cancer, IGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin and Chemotherapy
Arm Type
Experimental
Arm Description
Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)
Arm Title
Chemotherapy alone
Arm Type
Other
Arm Description
Chemotherapy is administered alone to Group B (n=50).
Intervention Type
Drug
Intervention Name(s)
MetFORMIN 500 Mg Oral Tablet
Other Intervention Name(s)
Glucophage 500 oral tablet and Chemotherapy
Intervention Description
MetFORMIN 500 Mg Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Chemotherapy alone
Intervention Description
The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).
Primary Outcome Measure Information:
Title
IGF-1 levels
Description
IGF-1 levels were measured before and after treatment.
Time Frame
6 months.
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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).
Time Frame
1 Year
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Marian S. Boshra
City
Banī Suwayf
ZIP/Postal Code
62514
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26293146
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.
Results Reference
background
PubMed Identifier
36233373
Citation
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.
Results Reference
background
PubMed Identifier
19029956
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.
Results Reference
result
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IGF Level in Breast Cancer Patients Treated With Metformin
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