Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions
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|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
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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
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|Ages Eligible for Study:||20 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Both genders with age range from 20 to 70 years.
- Patients able to return for the follow up visits and can perform oral hygiene measures.
- Clinically diagnosed and histologically confirmed as having oral potentially malignant lesions.
- Patients agreed to sign a written consent after understanding the nature of the study
- Patients have diagnosed oral premalignant lesion/lesions and not yet turned into malignancy (atrophic lichen planus- leukoplakia-erythroplakia - oral submucous fibrosis)
- - Diabetic patients (Diabetes Mellitus Type I & II)
- Patients have cardiovascular, lung, Renal, Liver diseases
- Patients on H2 blocker & proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)
- Those with allergy or sensitivity to Metformin or Retinoids therapy or having any contraindication for their use.
- Systemic and/or local systemic drug therapy within the last 3 months prior to the start of the study
- Patients on steroidal or Non-steroidal anti-inflammatory drugs (NSAIDs) for at least the last 6 months
- Patients on Antibiotics treatment for at least the last 2 months
- Patients on Retinoid, green tea supplements or another natural products therapy
- Patients with already diagnosed malignant lesion/lesions
- Pregnant or Lactating females
- Vulnerable groups as prisoners, mentally disabled, etc…
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|
|Cairo, New Cairo, Egypt, 11835|
|Contact: Noha N. El-Zalabany, Masters 1005365769 ext 02 firstname.lastname@example.org|
|Contact: Noha N. El-Zalabany, Masters 01005365769 ext 02 email@example.com|
|Study Chair:||Fathia Z. Zahran, PHD||Cairo University|
|Responsible Party:||Noha Nasr, Assistant Lecturer, Ain Shams University|
|Other Study ID Numbers:||
|First Posted:||September 26, 2018 Key Record Dates|
|Last Update Posted:||September 26, 2018|
|Last Verified:||September 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
Head and Neck Neoplasms
Neoplasms by Site
Physiological Effects of Drugs