Cancer Chemoprevention by Metformin Hydrochloride in Oral Potentially Malignant Lesions
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|ClinicalTrials.gov Identifier: NCT03685409|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
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 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.
Metformin, one of most widely prescribed oral hypoglycemic agents, has recently received increased attention because of its potential anti-tumorigenic effects that are thought to be independent of its hypoglycemic effects. Evans et al. first found an association between metformin use and decreased cancer incidence.
The study will reveal whether Systemic Metformin hydrochloride treatment given to patients with oral potentially malignant lesions improve the prognosis and prevent or at least reduce the incidence of malignant transformation?
|Condition or disease||Intervention/treatment||Phase|
|Oral Cancer||Drug: Metformin Hydrochloride 500 MG Drug: Placebo Oral Tablet||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomized Clinical Trial (Part 1)|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2020|
Active Comparator: Metformin-Group
Metformin hydrochloride tablets 500 mg taken orally once daily for 3 months
Drug: Metformin Hydrochloride 500 MG
Metformin hydrochloride tablets 500 mg given orally once daily.
Placebo Comparator: Placebo-Group
Starch placebo tablets taken orally once daily for 3 months
Drug: Placebo Oral Tablet
Starch Placebo oral tablets will be given once daily to the control group
- Clinical Outcomes [ Time Frame: 3 months ]Effect of Systemic Metformin hydrochloride on the millimeters change in the largest diameter of the oral potentially malignant lesion
- Immunohistochemical analysis [ Time Frame: 3 months ]Numerical change in immunohistochemical expression of Cyclin-D1 at baseline and at 3 months after using Metformin using computer aided image analysis
- microRNA analysis [ Time Frame: 3 months ]Numerical differences between miR-21 and miR-200 at baseline and at 3 months using Realtime PCR
- Salivary microRNA [ Time Frame: 3 months ]Numerical difference between the expression of miR-21 and miR-200 in tissue biopsies Versus Saliva at baseline and at 3 months
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): NCT03685409
|Faculty of Dentistry- Cairo University||Recruiting|
|Contact: Fatheya M Zahran, Professor 00201060775113 Fatheyazahran@gmail.com|
|Contact: Gihan G Madkour, As.Prof. 00201121001005 firstname.lastname@example.org|