IGF Level in Breast Cancer Patients Treated With Metformin

• Sponsor: Beni-Suef University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05840068
• Collaborator: (none)
• Enrollment: 107
• Location: 1
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site Per Month: 7.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Female	Drug: MetFORMIN 500 Mg Oral Tablet; Drug: Chemotherapy	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jul 31, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metformin and Chemotherapy Metformin (500 mg twice daily) plus chemotherapy is administered to Group A (n=57)	Drug: MetFORMIN 500 Mg Oral Tablet; MetFORMIN 500 Mg Oral Tablet; Other Names: Glucophage 500 oral tablet and Chemotherapy ; Drug: Chemotherapy; The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).; Other Names: Chemotherapy alone
Other: Chemotherapy alone Chemotherapy is administered alone to Group B (n=50).	Drug: Chemotherapy; The standard chemotherapy protocol developed by the South Egypt Cancer Institute (SECI).; Other Names: Chemotherapy alone

Outcome Measures

Primary Outcome Measures

1. IGF-1 levels [6 months.]

   IGF-1 levels were measured before and after treatment.

Secondary Outcome Measures

1. Progression-free survival (PFS) [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marian S. Boshra	Banī Suwayf		Egypt	62514

Sponsors and Collaborators

• Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Marian S. Boshra, Dr., Beni-Suef University
• ClinicalTrials.gov Identifier: NCT05840068
• Other Study ID Numbers: IGF level in breast cancer
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marian S. Boshra, Dr., Beni-Suef University: Metformin; Breast cancer; IGF
• Additional relevant MeSH terms: Breast Neoplasms; Metformin

Study Results

No Results Posted as of May 3, 2023