Oral CancerPhase 4NCT03684707
Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions
A Phase 4 study testing Metformin Hcl 500Mg 24Hr Sa Tab and starch tablet in people with Oral Cancer, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Metformin Hcl 500Mg 24Hr Sa Tab and starch tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2018to 15 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- - 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
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- 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…
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Noha Nasr
Cairo, New Cairo, 11835
Noha N. El-Zalabany, Masters, 1005365769 ext. 02, noha_nasr84@yahoo.com
Noha N. El-Zalabany, Masters, 01005365769 ext. 02, noha_nasr84@yahoo.com
About this study
Official title: Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomised Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Oral Cancer
- Being tested
- Metformin Hcl 500Mg 24Hr Sa Tab, starch tablet
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hcl 500Mg 24Hr Sa TabDrug
Also called Glucophage
Glucophage 500 mg once daily
starch tabletOther
starch tablets
| Study group | Role | What they receive |
|---|---|---|
| Metformin Hcl 500Mg 24Hr Sa Tab | Active comparator | Metformin Hcl 500Mg 24Hr Sa Tab drug is given to the patient Receives: Drug: Metformin Hcl 500Mg 24Hr Sa Tab |
| control | Placebo comparator | starch tablets Receives: Other: starch tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate lesion size in millimeters
Evaluate lesion size in millimeters
Measured: 1 year
Secondary outcomes (2)
Measurement of salivary Micro RNA
measuring salivary markers 31\& 210 in saliva and also in tissue biopsy
Measured: 1 year
Measuring immuno-histochemical marker
Measuring cyclin A2 marker in tissues
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start15 Sep 2018
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Nasr, Ain Shams University
- Investigators
- Fathia Z. Zahran, PHD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684707
- Sponsor's protocol ID
- Cairo University
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Chemoprevention by Metformin Hydrochloride Compared to Placebo in Oral Potentially Malignant Lesions: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03684707
- Acronym / sponsor ID
- Cairo University
- Conditions
- Oral Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trials
| Arm | Type | Receives |
|---|---|---|
| Metformin Hcl 500Mg 24Hr Sa Tab | Active comparator | Drug: Metformin Hcl 500Mg 24Hr Sa TabMetformin Hcl 500Mg 24Hr Sa Tab drug is given to the patient |
| control | Placebo comparator | Other: starch tabletstarch tablets |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Hcl 500Mg 24Hr Sa TabAlso: GlucophageGlucophage 500 mg once daily | Drug | Metformin Hcl 500Mg 24Hr Sa Tab |
| starch tabletstarch tablets | Other | control |
Primary outcome
Evaluate lesion size in millimeters
Time frame: 1 year
Evaluate lesion size in millimeters
2 secondary outcomes
Measurement of salivary Micro RNA
Time frame: 1 year
Measuring immuno-histochemical marker
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fathia Z. Zahran, PHD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Hcl 500Mg 24Hr Sa Tab and starch tablet in people with Oral Cancer, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha N. El-Zalabany, Masters (01005365769 ext. 02, noha_nasr84@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate lesion size in millimeters (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.