Breast Cancer Female Clinical Trial
Official title:
Metformin Effect as a Chemotherapeutic Adjuvant on Level of IGF in Non-diabetic Breast Cancer Patients
Verified date | May 2023 |
Source | Beni-Suef University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Marian S. Boshra | Bani Suwayf |
Lead Sponsor | Collaborator |
---|---|
Beni-Suef University |
Egypt,
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
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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