Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03684707|
Recruitment Status : Unknown
Verified September 2018 by Noha Nasr, Ain Shams University.
Recruitment status was: Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Evaluation of the metformin drug effect as a drug that found to improve the quality of tissues, decrease signs & symptoms of cancer, and decrease histo-pathological criteria of dysplasia.
This will be done by the aid of measuring salivary Micro RNA 31 & 210 in saliva in addition to measure cyclin A2 as an immuno-histochemical analysis.
|Condition or disease||Intervention/treatment||Phase|
|Oral Cancer||Drug: Metformin Hcl 500Mg 24Hr Sa Tab Other: starch tablet||Phase 4|
Oral squamous cell carcinomas (OSCCs) are among the most common types of head and neck cancers and are a major cause of significant morbidity. It was reported that 16- 62% of OSCCs develop from premalignant lesions, which often presents clinically as white or red mucosal patches known as leukoplakia and erythroplakia. The role of miRNA in cancer has been reiterated and established by many studies that have shown that miRNA signatures (i.e., mRNA expression profiles) can be useful for classifying human cancers. These studies have identified "cancer related miRNAs" through investigating expression profiles in matched normal and tumor tissues, as well as in body fluids. In addition, a vast number of studies have shown that miRNAs can play a role in regulating the expression of oncogenes and tumor suppressor genes, whereas others have shown that miRNA gene deletion or mutation can lead cancer initiation, progression and metastasis . Several potential mechanisms have been suggested for the ability of metformin to suppress cancer growth in vitro and vivo:
(1) Activation of LKB1/AMPK pathway, (2) Induction of cell cycle arrest and/or apoptosis, (3) Inhibition of protein synthesis, (4) Reduction in circulating insulin levels, (5) Inhibition of the unfolded protein response (UPR), (6) Activation of the immune system.
This study is performed to evaluate metformin effect on the patients premalignant lesion versus maintenace follow ups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized clinical trials|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomised Clinical Trial|
|Actual Study Start Date :||September 15, 2018|
|Estimated Primary Completion Date :||June 15, 2019|
|Estimated Study Completion Date :||September 15, 2019|
Active Comparator: Metformin Hcl 500Mg 24Hr Sa Tab
Metformin Hcl 500Mg 24Hr Sa Tab drug is given to the patient
Drug: Metformin Hcl 500Mg 24Hr Sa Tab
Glucophage 500 mg once daily
Other Name: Glucophage
Placebo Comparator: control
Other: starch tablet
- Evaluate lesion size in millimeters [ Time Frame: 1 year ]Evaluate lesion size in millimeters
- Measurement of salivary Micro RNA [ Time Frame: 1 year ]measuring salivary markers 31& 210 in saliva and also in tissue biopsy
- Measuring immuno-histochemical marker [ Time Frame: 1 year ]Measuring cyclin A2 marker in tissues
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684707
|Contact: Noha N. El-Zalabany, Masters||01005365769 ext firstname.lastname@example.org|
|Contact: Ahmed A. Abd El-Azim, Masters||01007975679 ext email@example.com|
|Study Chair:||Fathia Z. Zahran, PHD||Cairo University|